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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Nonabsorbable, Silk
510(k) Number K080684
Device Name WG-SURGICAL SUTURES WITH NEEDLE
Applicant
FOOSIN MEDICAL SUPPLIES INC.
SUITE 8D, ZHONGXIN ZHONGSHAN
MANSION, NO. 19 LANE 999
ZHONG SHAN, SHANGHAI,  CN 20030
Applicant Contact Diana Hong
Correspondent
FOOSIN MEDICAL SUPPLIES INC.
SUITE 8D, ZHONGXIN ZHONGSHAN
MANSION, NO. 19 LANE 999
ZHONG SHAN, SHANGHAI,  CN 20030
Correspondent Contact Diana Hong
Regulation Number878.5030
Classification Product Code
GAP  
Subsequent Product Codes
GAR   GAT   GAW  
Date Received03/10/2008
Decision Date 06/09/2008
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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