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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K130532
Device Name IDRIVE ULTRA STERILIZATION TRAY
Applicant
COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H
60 Middletown Ave
North Haven,  CT  06473
Applicant Contact KATHERINE ROBERTSON
Correspondent
COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H
60 Middletown Ave
North Haven,  CT  06473
Correspondent Contact KATHERINE ROBERTSON
Regulation Number880.6850
Classification Product Code
KCT  
Date Received03/01/2013
Decision Date 05/30/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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