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FDA 510(k)

BIMECO FILTERED EXTENSION SET

K-Number: K801605 · 1980-08-12

ApplicantBurron Medical Products, Inc.
Decision Date1980-08-12
Product CodeFPB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BIMECO FILTERED EXTENSION SET is the device name listed in this FDA 510(k) record. The listed applicant is Burron Medical Products, Inc.. It received FDA 510(k) clearance on 1980-08-12 under 510(k) number K801605. 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 BIMECO FILTERED EXTENSION SET?

BIMECO FILTERED EXTENSION SET is a medical device that received FDA 510(k) clearance on 1980-08-12. The listed applicant is Burron Medical Products, Inc.. The 510(k) number is K801605.

When did BIMECO FILTERED EXTENSION SET receive FDA 510(k) clearance?

BIMECO FILTERED EXTENSION SET received FDA 510(k) clearance on 1980-08-12, under 510(k) number K801605.

Who is the listed applicant for BIMECO FILTERED EXTENSION SET?

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

What is the FDA product code for BIMECO FILTERED EXTENSION SET?

The FDA product code for BIMECO FILTERED EXTENSION SET is FPB.

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Other records listing Burron Medical Products, Inc. as applicant

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K870403CAVAFIX(R) CENTRAL VENOUS CATHETER KIT W/SUTUREK862412INTESTOPLANTK861479CAVAFIX, CENTRAL VENOUS CATHETER KITK860126STIMUPLEX, NERVE STIMULATORK851293IMPLANTOFIXK841428JEJUNOSTOMY SET FOR TUBE FEEDING

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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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