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510(k) K944380

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 1994
Date Received
September 7, 1994
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

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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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