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510(k) K941447

SIMPLA S4, S5, S7 by Simpla Plastics , Ltd. — Product Code KNX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1994
Date Received
March 24, 1994
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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