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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, Steel, Monofilament And Multifilament, Sterile
510(k) Number K063603
Device Name SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17
Applicant
Suturtek Incorporated
6 Brookside Cir.
Acton,  MA  01720
Applicant Contact ART RANKIS
Correspondent
Suturtek Incorporated
6 Brookside Cir.
Acton,  MA  01720
Correspondent Contact ART RANKIS
Regulation Number878.4495
Classification Product Code
GAQ  
Date Received12/03/2006
Decision Date 02/07/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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