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510(k) K843698

CLOSED URINARY DRAINAGE UNIT by Pathfinder Intl. Corp. — Product Code KNX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1984
Date Received
September 20, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Collector, Urine, (And Accessories) For Indwelling Catheter
Device Class
Class II
Regulation Number
876.5250
Review Panel
GU
Submission Type

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