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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 K091087
Device Name MODIFICATION TO V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE
Applicant
Surgical Devices, Tyco Healthcare Group LP
60 Middletown Ave.
North Haven,  CT  06473
Applicant Contact JENNIFER BRENNAN
Correspondent
Surgical Devices, Tyco Healthcare Group LP
60 Middletown Ave.
North Haven,  CT  06473
Correspondent Contact JENNIFER BRENNAN
Regulation Number878.4493
Classification Product Code
GAM  
Date Received04/15/2009
Decision Date 04/22/2009
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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