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FDA 510(k)

INTRAVENOUS FILTER W/FLASH BULB

K-Number: K771827 · 1977-10-13

ApplicantJelco Laboratories
Decision Date1977-10-13
Product CodeFPB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INTRAVENOUS FILTER W/FLASH BULB is the device name listed in this FDA 510(k) record. The listed applicant is Jelco Laboratories. It received FDA 510(k) clearance on 1977-10-13 under 510(k) number K771827. 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 INTRAVENOUS FILTER W/FLASH BULB?

INTRAVENOUS FILTER W/FLASH BULB is a medical device that received FDA 510(k) clearance on 1977-10-13. The listed applicant is Jelco Laboratories. The 510(k) number is K771827.

When did INTRAVENOUS FILTER W/FLASH BULB receive FDA 510(k) clearance?

INTRAVENOUS FILTER W/FLASH BULB received FDA 510(k) clearance on 1977-10-13, under 510(k) number K771827.

Who is the listed applicant for INTRAVENOUS FILTER W/FLASH BULB?

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 INTRAVENOUS FILTER W/FLASH BULB?

The FDA product code for INTRAVENOUS FILTER W/FLASH BULB 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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