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510(k) K893135

GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER by Premium Plastics, Inc. — Product Code JOL

K893135 is an FDA 510(k) premarket notification submitted by Premium Plastics, Inc. for the device "GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER". The FDA issued a decision of Substantially Equivalent on June 22, 1989. The device falls under product code JOL (Catheter And Tip, Suction), a Class II device regulated under 21 CFR 880.6740. Premium Plastics, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1989
Date Received
April 25, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter And Tip, Suction
Device Class
Class II
Regulation Number
880.6740
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)
  • 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)
  • 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)

Other clearances for product code JOL

  • K051370 — STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F (August 12, 2005)
  • K000266 — PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION (July 12, 2001)
  • K000265 — PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION (July 12, 2001)
  • K003402 — WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FO (May 1, 2001)
  • K994321 — STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP (October 25, 2000)
  • K974758 — HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE (March 9, 1998)
  • K974759 — HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE (March 9, 1998)
  • K974397 — STERILE SALINE FOR CATHETER CARE (February 10, 1998)
  • K973734 — STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION (February 5, 1998)
  • K972372 — GERM TRAPPER SUCTION TUBE HOLDER (December 11, 1997)

FDA data resources