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FDA 510(k)

PREFILLED SODIUM CHLORIDE SOLUTION FOR IRRIGA. USP

K-Number: K880317 · 1988-02-29

ApplicantAutomatic Liquid Packaging, Inc.
Decision Date1988-02-29
Product CodeBTO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PREFILLED SODIUM CHLORIDE SOLUTION FOR IRRIGA. 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 K880317. 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 SODIUM CHLORIDE SOLUTION FOR IRRIGA. USP?

PREFILLED SODIUM CHLORIDE SOLUTION FOR IRRIGA. 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 K880317.

When did PREFILLED SODIUM CHLORIDE SOLUTION FOR IRRIGA. USP receive FDA 510(k) clearance?

PREFILLED SODIUM CHLORIDE SOLUTION FOR IRRIGA. USP received FDA 510(k) clearance on 1988-02-29, under 510(k) number K880317.

Who is the listed applicant for PREFILLED SODIUM CHLORIDE SOLUTION FOR IRRIGA. 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 SODIUM CHLORIDE SOLUTION FOR IRRIGA. USP?

The FDA product code for PREFILLED SODIUM CHLORIDE SOLUTION FOR IRRIGA. USP is BTO.

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Other records listing Automatic Liquid Packaging, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K994321STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USPK000964STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109K980147YOUR CHOICE MULTI-PURPOSE CONTACT LENS CLEANING SOLUTIONK973829IRRIGATION BOTTLEK962079HUMIDIFIER ADAPTERK955104HIGH FLOW ADJUSTABLE ENTRAINMENT NEBULIZER

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Related Devices (Code: BTO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253063Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series)Vitaltec CorporationK2429215300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mmVitaltec CorporationK233713Pilling Tracheostomy TubesTeleflex MedicalK192511Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mmVenner Medical (Singapore) Pte, Ltd.K173384BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tubeSmiths Medical Ads, Inc.K120079PRIMED TRACHEOSTOMY TUBES (MULTIPLE)Primed Halberstadt Medizintechnik GmbH

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.

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