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FDA 510(k)

TOP GUN

K-Number: K933742 · 1994-04-07

ApplicantBio-Medical Devices, Inc.
Decision Date1994-04-07
Product CodeFQH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TOP GUN is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Medical Devices, Inc.. It received FDA 510(k) clearance on 1994-04-07 under 510(k) number K933742. The device is classified under product code FQH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOP GUN?

TOP GUN is a medical device that received FDA 510(k) clearance on 1994-04-07. The listed applicant is Bio-Medical Devices, Inc.. The 510(k) number is K933742.

When did TOP GUN receive FDA 510(k) clearance?

TOP GUN received FDA 510(k) clearance on 1994-04-07, under 510(k) number K933742.

Who is the listed applicant for TOP GUN?

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

What is the FDA product code for TOP GUN?

The FDA product code for TOP GUN is FQH.

Other records listing Bio-Medical Devices, 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.

K040485MAXAIR SURGICAL HELMET SYSTEMK981888SMOKE-EVACK955149MAXI-FLOW SUCTION HANDLE/THE REEL THING TUBING REELK955151MAXI-FLOW SUCTION TUBE/TOP GUN SUCTION IRRIGATORK955150MAXI-FLOWK940156THE REEL THING

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Related Devices (Code: FQH)

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.

K253996BD Surgiphor™ Antimicrobial Irrigation System (910110)Becton, Dickinson and Company (BD)K253445BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)BdK231023ERBEJET® 2 SystemErbe Elektromedizin GmbHK220759Armis VeriCyn Wound WashArmis Biopharma, Inc.K220964VERSAJET Hydrosurgery System (III)Smith & Nephew Medical LimitedK221504BD Surgiphor™ Antimicrobial Irrigation SystemBd

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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