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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 K111442
Device Name V-LOC 180 ABSORBABLE RELOAD, V-LOC PBT NON-ABSORBABLE RELOAD, ENDO STITCH (TM) ENDOSCOPIC SUTURING DEVICE, SILS (TM)...
Applicant
Covidien, Formerly US Surgical A Divison of Tyco H
60 Middletown Ave.
North Haven,  CT  06473
Applicant Contact ROBERT ZOTT
Correspondent
Covidien, Formerly US Surgical A Divison of Tyco H
60 Middletown Ave.
North Haven,  CT  06473
Correspondent Contact ROBERT ZOTT
Regulation Number878.4493
Classification Product Code
GAM  
Subsequent Product Codes
GAT   OCW  
Date Received05/24/2011
Decision Date 06/03/2011
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
Recalls CDRH Recalls
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