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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 K120542
Model CH100, CH200, CH300, CH400, CH500, CH600
Device Name CARDINAL HEALTH DURABLUE STERILIZATION WRAP
Original Applicant
CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES
1430 waukegan rd.
mcgaw park,  IL  60085
Original Contact lavenia ford
Regulation Number880.6850
Classification Product Code
FRG  
Date Received02/23/2012
Decision Date 06/01/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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