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FDA 510(k)

ACRODISC FILTER ASSEMBLY

K-Number: K802765 · 1981-01-21

ApplicantGelman Sciences, Inc.
Decision Date1981-01-21
Product CodeFPB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ACRODISC FILTER ASSEMBLY is the device name listed in this FDA 510(k) record. The listed applicant is Gelman Sciences, Inc.. It received FDA 510(k) clearance on 1981-01-21 under 510(k) number K802765. 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 ACRODISC FILTER ASSEMBLY?

ACRODISC FILTER ASSEMBLY is a medical device that received FDA 510(k) clearance on 1981-01-21. The listed applicant is Gelman Sciences, Inc.. The 510(k) number is K802765.

When did ACRODISC FILTER ASSEMBLY receive FDA 510(k) clearance?

ACRODISC FILTER ASSEMBLY received FDA 510(k) clearance on 1981-01-21, under 510(k) number K802765.

Who is the listed applicant for ACRODISC FILTER ASSEMBLY?

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

What is the FDA product code for ACRODISC FILTER ASSEMBLY?

The FDA product code for ACRODISC FILTER ASSEMBLY is FPB.

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Other records listing Gelman Sciences, 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.

K946190DRUG DISPENSING SPIKEK943127PHARMASSURE LARGE VOLUME TRANSFER FILTERSK941589SYRINGE FILTER DEVICESK941020DRUG RECONSTITUTION FILTER DEVICEK942275VIAL VENT FILTERK941032UNKNOWN

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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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