FDA 510(k)

PREFILLED WATER FOR IRRIGATION USP

K-Number: K880316 · 1988-02-29

ApplicantAutomatic Liquid Packaging, Inc.

Decision Date1988-02-29

Product CodeBTO

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

PREFILLED WATER 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 1988-02-29 under 510(k) number K880316. The device is classified under product code BTO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREFILLED WATER FOR IRRIGATION USP?

PREFILLED WATER FOR IRRIGATION USP is a medical device that received FDA 510(k) clearance on 1988-02-29. The listed applicant is Automatic Liquid Packaging, Inc.. The 510(k) number is K880316.

When did PREFILLED WATER FOR IRRIGATION USP receive FDA 510(k) clearance?

PREFILLED WATER FOR IRRIGATION USP received FDA 510(k) clearance on 1988-02-29, under 510(k) number K880316.

Who is the listed applicant for PREFILLED WATER 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 PREFILLED WATER FOR IRRIGATION USP?

The FDA product code for PREFILLED WATER FOR IRRIGATION USP is BTO.

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Other records listing Automatic Liquid Packaging, Inc. as applicant

K994321STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP 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

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Related Devices (Code: BTO)

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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.