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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, Polyethylene
510(k) Number K103052
Device Name V-LOC(TM) NONABSORBABLE WOUND CLOSURE DEVICE
Applicant
Covidien LLC
60 MIDDLETOWN AVENUE
NORTH HAVEN,  CT  06473
Applicant Contact JENNIFER BRENNAN
Correspondent
Covidien LLC
60 MIDDLETOWN AVENUE
NORTH HAVEN,  CT  06473
Correspondent Contact JENNIFER BRENNAN
Regulation Number878.5000
Classification Product Code
GAT  
Date Received10/14/2010
Decision Date 11/10/2010
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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