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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name wrap, sterilization
510(k) Number K120658
Device Name DURABLUE STERILIZATION WRAP
Applicant
CARDINAL HEALTH 200, LLC
1430 WAUKEGAN ROAD
WAUKEGAN,  IL  60085
Applicant Contact LAVENIA FORD
Correspondent
CARDINAL HEALTH 200, LLC
1430 WAUKEGAN ROAD
WAUKEGAN,  IL  60085
Correspondent Contact LAVENIA FORD
Regulation Number880.6850
Classification Product Code
FRG  
Date Received03/05/2012
Decision Date 06/13/2012
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
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