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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 K080898
Device Name AUTO SUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS WITH STAPLE LINE REINFORCEMENT
Applicant
TYCO HEALTHCARE GROUP, LP
60 MIDDLETOWN AVE.
NORTH HAVEN,  CT  06473
Applicant Contact SHARON ALEXANDER
Correspondent
TYCO HEALTHCARE GROUP, LP
60 MIDDLETOWN AVE.
NORTH HAVEN,  CT  06473
Correspondent Contact SHARON ALEXANDER
Regulation Number878.4750
Classification Product Code
GDW  
Subsequent Product Code
GAG  
Date Received03/31/2008
Decision Date 05/05/2008
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
Recalls CDRH Recalls
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