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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscopic tissue approximation device
510(k) Number K090470
Device Name AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES
Applicant
COVIDIEN
60 MIDDLETWON DR
NORTH HAVEN,  CT  06473
Applicant Contact JENNIFER BRENNAN
Correspondent
COVIDIEN
60 MIDDLETWON DR
NORTH HAVEN,  CT  06473
Correspondent Contact JENNIFER BRENNAN
Regulation Number876.1500
Classification Product Code
OCW  
Subsequent Product Code
GDW  
Date Received02/23/2009
Decision Date 05/14/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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