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FDA 510(k)

Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135

K-Number: K213457 · 2022-03-02

ApplicantFort Defiance Industries, LLC
Decision Date2022-03-02
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135 is the device name listed in this FDA 510(k) record. The listed applicant is Fort Defiance Industries, LLC. It received FDA 510(k) clearance on 2022-03-02 under 510(k) number K213457. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135?

Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135 is a medical device that received FDA 510(k) clearance on 2022-03-02. The listed applicant is Fort Defiance Industries, LLC. The 510(k) number is K213457.

When did Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135 receive FDA 510(k) clearance?

Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135 received FDA 510(k) clearance on 2022-03-02, under 510(k) number K213457.

Who is the listed applicant for Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135?

The FDA 510(k) record lists Fort Defiance Industries, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135?

The FDA product code for Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135 is FLE.

Related Clinical Trials

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.

NCT07357168Electromagnetic Field Therapy Versus Aerobic Exercise on Prostatic Function in Elderly With Benign Prostatic HyperplasiaENROLLING_BY_INVITATION

Other records listing Fort Defiance Industries, LLC 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.

K243801FRONT-LINE Field Sterilizer (FL135)

Related Devices (Code: FLE)

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.

K261055AMSCO 700 Steam SterilizerSTERIS CorporationK260254Enbio PROEnbio Group AGK252307Getinge GSS67N Series Steam SterilizerMaquet GmbH (A Getinge Group Company)K250168Life Ultra 25L Tabletop Mono Chamber Steam SterilizerLucas LifecareK250164Cassette Autoclave (ACA5)Guangzhou Ajax Medical Equipment Co., Ltd.K243994Steam Sterilizer (2545D)Ningbo Ican Machines Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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