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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 K020901
Device Name SERRALSILK
Applicant
Serral, S.A. DE C.V.
5251-18 John Tyler Hwy,
Suite 167
Williamsburg,  VA  23185
Applicant Contact SCOTT HENDERSON
Correspondent
Serral, S.A. DE C.V.
5251-18 John Tyler Hwy,
Suite 167
Williamsburg,  VA  23185
Correspondent Contact SCOTT HENDERSON
Regulation Number878.5030
Classification Product Code
GAP  
Date Received03/20/2002
Decision Date 04/26/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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