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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Absorbable, Synthetic, Polyglycolic Acid
510(k) Number K082662
Device Name V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE
Applicant
SURGICAL DEVICES, TYCO HEALTHCARE GROUP LP
60 MIDDLETOWN AVE.
NORTH HAVEN,  CT  06473
Applicant Contact RENEE BORGESANO
Correspondent
SURGICAL DEVICES, TYCO HEALTHCARE GROUP LP
60 MIDDLETOWN AVE.
NORTH HAVEN,  CT  06473
Correspondent Contact RENEE BORGESANO
Regulation Number878.4493
Classification Product Code
GAM  
Date Received09/12/2008
Decision Date 03/26/2009
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
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