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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Surgical, Absorbable, Polydioxanone
510(k) Number K073614
Device Name WG-SURGICAL SUTURES WITH NEEDLE
Applicant
Foosin Medical Supplies, Inc.
Suite 8d, Zhongxin Zhongshan
Mansion, # 19 Lane 999
Zhong Shan, Shanghai,  CN 20030
Applicant Contact Diana Hong
Correspondent
Foosin Medical Supplies, Inc.
Suite 8d, Zhongxin Zhongshan
Mansion, # 19 Lane 999
Zhong Shan, Shanghai,  CN 20030
Correspondent Contact Diana Hong
Regulation Number878.4840
Classification Product Code
NEW  
Subsequent Product Code
GAM  
Date Received12/26/2007
Decision Date 04/30/2008
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
Predetermined Change
Control Plan Authorized		 No
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