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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Implantable
510(k) Number K123109
Device Name ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE
Applicant
COVIDIEN
60 MIDDLETOWN AVE.
NORTH HAVEN,  CT  06473
Applicant Contact RENEE BORGESANO
Correspondent
COVIDIEN
60 MIDDLETOWN AVE.
NORTH HAVEN,  CT  06473
Correspondent Contact RENEE BORGESANO
Regulation Number878.4750
Classification Product Code
GDW  
Date Received10/04/2012
Decision Date 10/23/2012
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
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