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510(k) K954752

PEDIATRIC EUROPHYLIC FOLEY CATHETER by Regulatory & Marketing Services, Inc. — Product Code EZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1995
Date Received
October 16, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Retention Type, Balloon
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Regulatory & Marketing Services, Inc.

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  • K944673 — MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE (April 10, 1996)
  • K941342 — PAIN DOC (October 13, 1995)
  • K941543 — DIAL MEDICAL KIT (February 16, 1995)
  • K944378 — ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAG (February 15, 1995)
  • K944384 — ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG (February 15, 1995)
  • K944379 — ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG (February 15, 1995)
  • K945874 — EUROMEDICAL POLY TRACHEOTOMY TUBE (December 27, 1994)
  • K944377 — ORION'S URINARY DRAINAGE SET (December 6, 1994)
  • K944383 — ORION RED URETHRAL CATHETER (December 6, 1994)

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