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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 K032468
Device Name SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE
Applicant
Suturtek Incorporated
7 Tiffany Trl.
Hopkonton,  MA  01748
Applicant Contact DEBBIE IAMPIETRO
Correspondent
Suturtek Incorporated
7 Tiffany Trl.
Hopkonton,  MA  01748
Correspondent Contact DEBBIE IAMPIETRO
Regulation Number878.4495
Classification Product Code
GAQ  
Date Received08/11/2003
Decision Date 09/23/2003
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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