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510(k) K941543

DIAL MEDICAL KIT by Regulatory & Marketing Services, Inc. — Product Code KOC

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
February 16, 1995
Date Received
March 30, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Blood Circuit, Hemodialysis
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Regulatory & Marketing Services, Inc.

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  • K954752 — PEDIATRIC EUROPHYLIC FOLEY CATHETER (October 30, 1995)
  • K941342 — PAIN DOC (October 13, 1995)
  • K944379 — ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG (February 15, 1995)
  • K944384 — ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG (February 15, 1995)
  • K944378 — ORION'S URETHRAL 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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