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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 K100257
Device Name VLOC9ABSORBABLE WOUND CLOSURE DEVICE
Applicant
Surgical Devices, A Division of Tyco Healthcare
60 Middletown Ave.
North Haven,  CT  06473
Applicant Contact JENNIFER BRENNAN
Correspondent
Surgical Devices, A Division of Tyco Healthcare
60 Middletown Ave.
North Haven,  CT  06473
Correspondent Contact JENNIFER BRENNAN
Regulation Number878.4493
Classification Product Code
GAM  
Date Received01/28/2010
Decision Date 05/10/2010
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
Predetermined Change
Control Plan Authorized		 No
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