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FDA 510(k)

PHARMASSURE LARGE VOLUME TRANSFER FILTERS

K-Number: K943127 · 1994-09-29

ApplicantGelman Sciences, Inc.
Decision Date1994-09-29
Product CodeFPB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PHARMASSURE LARGE VOLUME TRANSFER FILTERS 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 1994-09-29 under 510(k) number K943127. 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 PHARMASSURE LARGE VOLUME TRANSFER FILTERS?

PHARMASSURE LARGE VOLUME TRANSFER FILTERS is a medical device that received FDA 510(k) clearance on 1994-09-29. The listed applicant is Gelman Sciences, Inc.. The 510(k) number is K943127.

When did PHARMASSURE LARGE VOLUME TRANSFER FILTERS receive FDA 510(k) clearance?

PHARMASSURE LARGE VOLUME TRANSFER FILTERS received FDA 510(k) clearance on 1994-09-29, under 510(k) number K943127.

Who is the listed applicant for PHARMASSURE LARGE VOLUME TRANSFER FILTERS?

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 PHARMASSURE LARGE VOLUME TRANSFER FILTERS?

The FDA product code for PHARMASSURE LARGE VOLUME TRANSFER FILTERS 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 SPIKEK941589SYRINGE FILTER DEVICESK941020DRUG RECONSTITUTION FILTER DEVICEK942275VIAL VENT FILTERK941032UNKNOWNK910821TRANSDUCER PROTECTOR

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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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