FDA 510(k)

STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP

K-Number: K994321 · 2000-10-25

ApplicantAutomatic Liquid Packaging, Inc.

Decision Date2000-10-25

Product CodeJOL

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP is the device name listed in this FDA 510(k) record. The listed applicant is Automatic Liquid Packaging, Inc.. It received FDA 510(k) clearance on 2000-10-25 under 510(k) number K994321. The device is classified under product code JOL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP?

STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP is a medical device that received FDA 510(k) clearance on 2000-10-25. The listed applicant is Automatic Liquid Packaging, Inc.. The 510(k) number is K994321.

When did STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP receive FDA 510(k) clearance?

STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP received FDA 510(k) clearance on 2000-10-25, under 510(k) number K994321.

Who is the listed applicant for STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP?

The FDA 510(k) record lists Automatic Liquid Packaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP?

The FDA product code for STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP is JOL.

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Other records listing Automatic Liquid Packaging, Inc. as applicant

K000964STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109 K980147YOUR CHOICE MULTI-PURPOSE CONTACT LENS CLEANING SOLUTION K973829IRRIGATION BOTTLE K962079HUMIDIFIER ADAPTER K955104HIGH FLOW ADJUSTABLE ENTRAINMENT NEBULIZER K920306OPTI-MOL FILTERED PUNCTURE PIN

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Related Devices (Code: JOL)

K051370STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014Baxter Healthcare Corp K000265PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATIONPrimary Care Solutions, Inc.K000266PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATIONPrimary Care Solutions, Inc.K003402WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATIONWelcon, Inc.K974758HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLEHydrox Laboratories K974759HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLEHydrox Laboratories

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.