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510(k) K936261

CATHETER INSERTION TRAY by Medcare Custom Packaging, Inc. — Product Code FMI

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
March 10, 1994
Date Received
December 20, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

Other clearances by Medcare Custom Packaging, Inc.

  • K954869 — MEDCARE YANKAUER SUCTION DEVICE (January 19, 1996)
  • K954442 — STERILE ISOTONIC SALINE & STERILE WATER (December 21, 1995)
  • K952759 — TOWEL PACK (September 29, 1995)
  • K950390 — URETHRAL CATHETERIZATION TRAY (May 30, 1995)
  • K943661 — STERILE PHYSIOLOGICAL SALINE/STERILE WATER (April 10, 1995)
  • K951149 — SINGLE USE INSTRUMENT TRAY (April 6, 1995)
  • K934732 — PELVIC EXAM TRAY (December 30, 1994)
  • K942000 — BURN DRESSING TRAY (May 20, 1994)
  • K922179 — CATHETER INSERTION TRAY (July 2, 1993)
  • K901856 — CUSTOM WOUND MANAGEMENT KITS AND TRAYS (August 1, 1990)

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