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510(k) K944377

ORION'S URINARY DRAINAGE SET by Regulatory & Marketing Services, Inc. — Product Code KNX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1994
Date Received
September 7, 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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  • K944384 — ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG (February 15, 1995)
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  • K944378 — ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAG (February 15, 1995)
  • K945874 — EUROMEDICAL POLY TRACHEOTOMY TUBE (December 27, 1994)
  • K944383 — ORION RED URETHRAL CATHETER (December 6, 1994)

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  • K962652 — URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) (October 4, 1996)
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