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510(k) K962078

TRACHEOSTOMY CLEANING TRAY W/SUCTION CATHETER by Continental Medical Laboratories, Inc. — Product Code JOH

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
October 11, 1996
Date Received
May 28, 1996
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 Continental Medical Laboratories, Inc.

  • K964827 — PROD. NO. 01-132 - SUTURE REMOVAL KIT (February 14, 1997)
  • K963234 — STAPLE REMOVAL KIT (October 21, 1996)
  • K963443 — PROD. NO. 02-031 - LACERATION TRAY (October 17, 1996)
  • K954728 — PROD NO. 01-1694 - 4X4 FOAM DRESSING (September 23, 1996)
  • K962073 — URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY (June 21, 1996)
  • K952335 — WOUND CARE MANAGEMENT KITS (June 14, 1995)
  • K905123 — G-TUBE DRESSING CHANGE TRAY (March 27, 1991)

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