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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 K123318
Device Name IDRIVE ULTRA POWERED HANDLE AND ENDO GIA ADAPTER
Applicant
Covidien, Formerly US Surgical A Divison of Tyco H
60 Middletown Ave.
North Haven,  CT  06473
Applicant Contact SARAH RIZK
Correspondent
Covidien, Formerly US Surgical A Divison of Tyco H
60 Middletown Ave.
North Haven,  CT  06473
Correspondent Contact SARAH RIZK
Regulation Number878.4750
Classification Product Code
GDW  
Date Received10/25/2012
Decision Date 12/18/2012
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
Predetermined Change
Control Plan Authorized		 No
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