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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 K122507
Device Name DURABLUE STERILIZATION WRAP, MODEL NUMBERS CH100, CH200, CH300, CH400, CH500 AND CH600, STERRAD NX STERILIZATION
Applicant
CARDINAL HEALTH 200, LLC
1430 waukegan road
waukegan,  IL  60085
Contact lavenia ford
Regulation Number880.6850
Classification Product Code
FRG  
Date Received08/17/2012
Decision Date 09/26/2012
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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