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FDA 510(k)

1.2 MICRON FILTER WITH IV SET

K-Number: K896292 · 1989-12-08

ApplicantKendall Mcgaw Laboratories, Inc.
Decision Date1989-12-08
Product CodeFPB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

1.2 MICRON FILTER WITH IV SET is the device name listed in this FDA 510(k) record. The listed applicant is Kendall Mcgaw Laboratories, Inc.. It received FDA 510(k) clearance on 1989-12-08 under 510(k) number K896292. The device is classified under product code FPB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 1.2 MICRON FILTER WITH IV SET?

1.2 MICRON FILTER WITH IV SET is a medical device that received FDA 510(k) clearance on 1989-12-08. The listed applicant is Kendall Mcgaw Laboratories, Inc.. The 510(k) number is K896292.

When did 1.2 MICRON FILTER WITH IV SET receive FDA 510(k) clearance?

1.2 MICRON FILTER WITH IV SET received FDA 510(k) clearance on 1989-12-08, under 510(k) number K896292.

Who is the listed applicant for 1.2 MICRON FILTER WITH IV SET?

The FDA 510(k) record lists Kendall Mcgaw Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 1.2 MICRON FILTER WITH IV SET?

The FDA product code for 1.2 MICRON FILTER WITH IV SET is FPB.

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Other records listing Kendall Mcgaw Laboratories, 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.

K905610MICRORATE INTELLIGENT PUMPK905611MICRORATE PLUS INTELLIGENT PUMPK904855ADD-A-VIALK904518VOLUMETRIC INFUSION PUMPK903809PROTECTED NEEDLE WITH OR WITHOUT IV SETK901065INFUSION PUMP

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Related Devices (Code: FPB)

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.

K261403Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion FilterGlobal Life Sciences Solutions USA, LLCK233277Filter Needle for Single UseHangzhou Qiantang Longyue Biotechnology Co., Ltd.K113227NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTERBaxter Healthcare CorpK021293ARTERIA BLOOD FILTERArteria Medical Science, Inc.K993379PALL SUPOR AEF FILTERPall Corp.K9746610.2 U BACTERIAL FILTERSims Deltec, Inc.

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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