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510(k) K130927

DURABLUE STERILIZATION WRAP by Cardinal Health200, LLC — Product Code FRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2013
Date Received
April 3, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wrap, Sterilization
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type

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