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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 K994177
Device Name SUTRASILK SILK SUTURE
Applicant
Visionary Medical Supplies, Inc.
4740 Connecticut Ave. NW
Suite 708
Washington,  DC  20008
Applicant Contact JONATHAN GREEN
Correspondent
Visionary Medical Supplies, Inc.
4740 Connecticut Ave. NW
Suite 708
Washington,  DC  20008
Correspondent Contact JONATHAN GREEN
Regulation Number878.5030
Classification Product Code
GAP  
Date Received12/10/1999
Decision Date 02/08/2000
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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