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FDA 510(k)

AIR VENT FILTER NEEDLE, 0.45

K-Number: K771536 · 1977-10-25

ApplicantJelco Laboratories
Decision Date1977-10-25
Product CodeFPB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AIR VENT FILTER NEEDLE, 0.45 is the device name listed in this FDA 510(k) record. The listed applicant is Jelco Laboratories. It received FDA 510(k) clearance on 1977-10-25 under 510(k) number K771536. 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 AIR VENT FILTER NEEDLE, 0.45?

AIR VENT FILTER NEEDLE, 0.45 is a medical device that received FDA 510(k) clearance on 1977-10-25. The listed applicant is Jelco Laboratories. The 510(k) number is K771536.

When did AIR VENT FILTER NEEDLE, 0.45 receive FDA 510(k) clearance?

AIR VENT FILTER NEEDLE, 0.45 received FDA 510(k) clearance on 1977-10-25, under 510(k) number K771536.

Who is the listed applicant for AIR VENT FILTER NEEDLE, 0.45?

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

What is the FDA product code for AIR VENT FILTER NEEDLE, 0.45?

The FDA product code for AIR VENT FILTER NEEDLE, 0.45 is FPB.

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Other records listing Jelco Laboratories 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.

K791918JELCO WINGED INTRAVASCULAR CATHETERK791372JELCO & KVO CATHETER PLACEMENT UNITK790967CATHETER METAL HUB/RADIOPAQUEK790968CATHETER METAL HUB/NONRADIOPAQUEK790471JELCO* DISC FILTER-0.2 MICRONK790186PROTECTIVSTABILIZER

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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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