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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 K062125
Device Name SUPERSTITCH 5F, 12F, AND EL
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 Received07/25/2006
Decision Date 10/19/2006
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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