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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 K012124
Device Name MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP
Applicant
Johnson & Johnson Medical (China) , Ltd.
#75 Nan Gu Zhi Rd.
Monhang, Shanghai,  CN 200245
Applicant Contact BEN TANG
Correspondent
Johnson & Johnson Medical (China) , Ltd.
#75 Nan Gu Zhi Rd.
Monhang, Shanghai,  CN 200245
Correspondent Contact BEN TANG
Regulation Number878.5030
Classification Product Code
GAP  
Date Received07/06/2001
Decision Date 09/19/2001
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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