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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 K102325
Device Name IDRIVE SYSTEM (I DRIVE POWER HANDLE, IDRIVE (RALC) SINGLE USE RELOAD)
Applicant
COVIDIEN LLC, FORMERLY REGISTERED AS TYCO HEALTHCA
60 Middletown Ave
North Haven,  CT  06473
Applicant Contact NISHITH DESAI
Correspondent
COVIDIEN LLC, FORMERLY REGISTERED AS TYCO HEALTHCA
60 Middletown Ave
North Haven,  CT  06473
Correspondent Contact NISHITH DESAI
Regulation Number878.4750
Classification Product Code
GDW  
Date Received08/17/2010
Decision Date 10/13/2010
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
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