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510(k) K945874

EUROMEDICAL POLY TRACHEOTOMY TUBE by Regulatory & Marketing Services, Inc. — Product Code JOH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1994
Date Received
December 1, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube Tracheostomy And Tube Cuff
Device Class
Class II
Regulation Number
868.5800
Review Panel
AN
Submission Type

Other clearances by Regulatory & Marketing Services, Inc.

  • K101721 — WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA (March 24, 2011)
  • K944673 — MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE (April 10, 1996)
  • K954752 — PEDIATRIC EUROPHYLIC FOLEY CATHETER (October 30, 1995)
  • K941342 — PAIN DOC (October 13, 1995)
  • K941543 — DIAL MEDICAL KIT (February 16, 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)
  • K944378 — ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAG (February 15, 1995)
  • K944383 — ORION RED URETHRAL CATHETER (December 6, 1994)
  • K944377 — ORION'S URINARY DRAINAGE SET (December 6, 1994)

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