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510(k) K130404

TIBURON SURGICAL DRAPE by Cardinal Health200, LLC — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 2013
Date Received
February 19, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drape, Surgical
Device Class
Class II
Regulation Number
878.4370
Review Panel
HO
Submission Type

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