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510(k) K080845

ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM by Cardinalhealth — Product Code JCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2008
Date Received
March 26, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Apparatus, Suction, Ward Use, Portable, Ac-Powered
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type

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