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510(k) K890107

GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT by Premium Plastics, Inc. — Product Code FRO

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
October 24, 1989
Date Received
January 11, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
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)
  • 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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