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510(k) K925067

SIMPLA TRIDENT LEG BAG + SIMPLA S6 BAG by Simport Plastics, Ltd. — Product Code KNX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1993
Date Received
October 5, 1992
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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