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510(k) K850285

GENT-L-KARE STERILE URETHRAL CATHETERIZATION TRAY by Premium Plastics, Inc. — Product Code KOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1985
Date Received
January 23, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urological
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Premium Plastics, Inc.

  • K953226 — PULM O2 SUCTION CATHETER TRAYS (August 8, 1995)
  • K950851 — GENT-L-KARE TRACHEOSTOMY TRAYS (June 21, 1995)
  • K950850 — GENT-L-KARE LACERATION TRAYS (March 14, 1995)
  • K943740 — ROLL-A-WAY SHARPS DISPOSAL SYSTEM (RED AND IVORY) (December 14, 1994)
  • K890107 — GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT (October 24, 1989)
  • K893135 — GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER (June 22, 1989)
  • K800440 — STERILE SPONGE BOWLS (April 29, 1980)
  • K771448 — STERILE SUTURE REMOVAL KIT (September 6, 1977)

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