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510(k) K921733

TRACHEOSTOMY CARE TRAY by Medikmark, Inc. — Product Code JOH

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
June 15, 1994
Date Received
April 10, 1992
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 Medikmark, Inc.

  • K953474 — IV START KIT (October 2, 1995)
  • K923960 — UPPER EXTERMITY DRAPE KIT (October 7, 1994)
  • K921730 — C-SECTION PACK (June 15, 1994)
  • K921732 — MINOR LAP SET (June 15, 1994)
  • K920340 — SUTURE REMOVAL KIT (April 23, 1992)
  • K920339 — DRESSING CHANGE TRAY (April 23, 1992)
  • K920341 — LACERATION TRAYS (April 23, 1992)

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  • K193133 — Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Mult (December 12, 2019)
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  • K173912 — BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Perc (May 8, 2018)
  • K180034 — Weinmann Tracheostomy Exchange Set (May 7, 2018)
  • K172720 — TRACOE silcosoft Tracheostomy Tube (April 27, 2018)
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