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510(k) K950390

URETHRAL CATHETERIZATION TRAY by Medcare Custom Packaging, Inc. — Product Code FCM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 1995
Date Received
February 1, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Medcare Custom Packaging, Inc.

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  • K954442 — STERILE ISOTONIC SALINE & STERILE WATER (December 21, 1995)
  • K952759 — TOWEL PACK (September 29, 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)
  • K936261 — CATHETER INSERTION TRAY (March 10, 1994)
  • K922179 — CATHETER INSERTION TRAY (July 2, 1993)
  • K901856 — CUSTOM WOUND MANAGEMENT KITS AND TRAYS (August 1, 1990)

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