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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, Synthetic, Polypropylene
510(k) Number K053482
Device Name SUPERSTITCH GW, MODELS 06-15-04-GW, 08-15-04-GW
Applicant
Sutura, Inc.
555 Thirteenth St. NW
Washington,  DC  20004
Applicant Contact GERARD J PRUD'HOMME
Correspondent
Sutura, Inc.
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact GERARD J PRUD'HOMME
Regulation Number878.5010
Classification Product Code
GAW  
Date Received12/14/2005
Decision Date 12/27/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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