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510(k) K812312

STERILE WATER 4OZ. by Superior Plastic Products Corp. — Product Code JOL

K812312 is an FDA 510(k) premarket notification submitted by Superior Plastic Products Corp. for the device "STERILE WATER 4OZ.". The FDA issued a decision of Substantially Equivalent on November 13, 1981. The device falls under product code JOL (Catheter And Tip, Suction), a Class II device regulated under 21 CFR 880.6740. Superior Plastic Products Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1981
Date Received
August 17, 1981
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 Superior Plastic Products Corp.

  • K851981 — NO. 5300-3 1/2 FRENCH UMBILICAL VESSEL CATH. ETC. (June 18, 1985)
  • K843975 — 9 FRENCH 42LONG POLYURETHANE GRADUATED ENTERIC FE (November 20, 1984)
  • K841945 — ENTERAL FEEDING BOTTLE (July 26, 1984)
  • K841630 — ENTERAL NUTRITION PUMP (June 7, 1984)
  • K841480 — INFECTION CONTROL VALVE (April 25, 1984)
  • K840324 — SILICONE SUMP DRAIN 20 & 40 FRENCH (April 25, 1984)
  • K840323 — SILICONE SUCTION & IRRIGATION DRAIN (April 25, 1984)
  • K833687 — DISPOS. ENTERIC FEEDING TUBES W/SAFE-T (March 2, 1984)
  • K833947 — SUPERIOR ENTERNAL FEEDING SYSTEM (February 4, 1984)
  • K820460 — 3.5 & 5.5 OZ. SODIUM CHLORIDE SOLUTION (March 8, 1982)

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