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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Absorbable, Synthetic, Polyglycolic Acid
510(k) Number K130737
Device Name SYNTHETIC ABSORBABLE SUTURE
Applicant
FOOSIN MEDICAL SUPPLIES INC.LTD
PO BOX 120-119
SHANGHAI,  CN 200120
Applicant Contact Diana Hong
Correspondent
FOOSIN MEDICAL SUPPLIES INC.LTD
PO BOX 120-119
SHANGHAI,  CN 200120
Correspondent Contact Diana Hong
Regulation Number878.4493
Classification Product Code
GAM  
Date Received03/18/2013
Decision Date 01/14/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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