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510(k) K994321

STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP by Automatic Liquid Packaging, Inc. — Product Code JOL

K994321 is an FDA 510(k) premarket notification submitted by Automatic Liquid Packaging, Inc. for the device "STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP". The FDA issued a decision of Substantially Equivalent on October 25, 2000. The device falls under product code JOL (Catheter And Tip, Suction), a Class II device regulated under 21 CFR 880.6740. Automatic Liquid Packaging, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2000
Date Received
December 22, 1999
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 Automatic Liquid Packaging, Inc.

  • K000964 — STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109 (April 25, 2000)
  • K980147 — YOUR CHOICE MULTI-PURPOSE CONTACT LENS CLEANING SOLUTION (April 13, 1998)
  • K973829 — IRRIGATION BOTTLE (February 23, 1998)
  • K962079 — HUMIDIFIER ADAPTER (July 31, 1996)
  • K955104 — HIGH FLOW ADJUSTABLE ENTRAINMENT NEBULIZER (June 11, 1996)
  • K920306 — OPTI-MOL FILTERED PUNCTURE PIN (April 6, 1992)
  • K911770 — OPTIMOL RESPIRATORY HUMIDIFICATION SYSTEM (October 15, 1991)
  • K901762 — PREFILLED FLEXIBLE R.T. CONTAINERS W/STER. SODIUM (July 17, 1990)
  • K901362 — ACCESSORY FITMENT TO NEBULIZER SYSTEM, STERILE (June 6, 1990)
  • K901301 — STER INHAL SOLUT PREFIL BTL W/ADJUST ENTRAIN NEBUL (May 31, 1990)

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)
  • K974759 — HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE (March 9, 1998)
  • K974758 — HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 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)
  • K960216 — CPR SUCTION CATHETER KIT (April 15, 1996)

FDA data resources