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510(k) K950850

GENT-L-KARE LACERATION TRAYS by Premium Plastics, Inc. — Product Code FRG

Clearance Details

Decision
SN ()
Decision Date
March 14, 1995
Date Received
February 24, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wrap, Sterilization
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
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)
  • 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)
  • K850285 — GENT-L-KARE STERILE URETHRAL CATHETERIZATION TRAY (February 28, 1985)
  • K800440 — STERILE SPONGE BOWLS (April 29, 1980)
  • K771448 — STERILE SUTURE REMOVAL KIT (September 6, 1977)

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  • K243431 — Medicom Sterilization Pouch and Reel (February 21, 2025)
  • K242898 — Sterilization Pouches and Reels (February 21, 2025)