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ISO 10993
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41	OCT 20 P.O. Box 708 Warsaw, IN[removed][removed] Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2011-11-28 00:37:48 Pharmaceutical industry Clinical research Food law Code of Federal Regulations Premarket approval Title 21 of the Code of Federal Regulations Center for Devices and Radiological Health Validation ISO 10993 Medicine Food and Drug Administration Health
42	Concentric Medical, Inc. Traditional 510(k) Submission, K131492 510(k) Summary Trade Name: Common Name: Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2013-11-14 08:33:13 Biocompatibility Predicate Package testing Percutaneous ISO 10993 Medicine Surgery Catheter
43	V/V(3 Section[removed]k) Summary SUBMIrrER INFORMATION Benson Medical Instruments Company Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2013-10-09 09:33:37 Food and Drug Administration Pulmonary function testing Pharmaceutical industry Quality management Spirometer Spirometry Medical device ISO 10993 Premarket approval Medicine Health Respiratory therapy
44	1C210 O30 610(k) SUMMARY Sacks Holdings, Inc. Contact Lens Storage Case Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2012-08-06 18:53:08 Contact lenses Technology Optometry Optical devices Camera lens Medical device Rigid gas permeable Lens ISO 10993 Medicine Optics Corrective lenses
45	PDF Document Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2011-05-30 00:44:09 Health Medical equipment Food law Pharmaceuticals policy Medical device Medical technology ISO 10993 Hypodermic needle Premarket approval Medicine Food and Drug Administration Technology
46	MAR[removed]k) Summary Contact in formation Submitter: Mr. Takeshi Yuasa General Manager, Overseas Regulatory Affairs Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2013-04-11 12:52:56 Food and Drug Administration Medical equipment Food law Catheters Medical device Infusion set Port ISO 10993 Federal Food Drug and Cosmetic Act Medicine Medical technology Health
47	MAY-4"2012 Unined Medical Supplies Inc. No. 37, Yanshan Road, Shekou, Shenzhen, China[removed]Tel: [removed]Fax: [removed]Email: [removed] Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2012-06-11 00:35:10 Food and Drug Administration Medical equipment Food law Medical technology Blood pressure Medical device Sphygmomanometer Premarket approval ISO 10993 Medicine Technology Health
48	EM ERGO §GROUP SEP[removed] Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2011-10-31 00:33:05 Prosthodontology Dental materials Dental restorative materials Crown Medical device Dental composite ISO 10993 Bridge Premarket approval Medicine Restorative dentistry Health
49	132z,1q DEC 510(k) Summary Date prepared: Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2014-01-14 08:01:21 Food and Drug Administration Pharmaceutical industry Validity Quality management Food law Medical device ISO 10993 Validation Quality management system Medicine Technology Health
50	PDF Document Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2011-06-27 00:48:18 Medical device Medical technology ISO 10993 Laparoscopic surgery Biocompatibility Food and Drug Administration Sterilization Document management system Medicine Medical equipment Endoscopy

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