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FDA 510(k)

STERILEMAX

K-Number: K953938 · 1997-01-30

ApplicantBarnstead/Thermolyne Corp.
Decision Date1997-01-30
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERILEMAX is the device name listed in this FDA 510(k) record. The listed applicant is Barnstead/Thermolyne Corp.. It received FDA 510(k) clearance on 1997-01-30 under 510(k) number K953938. 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 STERILEMAX?

STERILEMAX is a medical device that received FDA 510(k) clearance on 1997-01-30. The listed applicant is Barnstead/Thermolyne Corp.. The 510(k) number is K953938.

When did STERILEMAX receive FDA 510(k) clearance?

STERILEMAX received FDA 510(k) clearance on 1997-01-30, under 510(k) number K953938.

Who is the listed applicant for STERILEMAX?

The FDA 510(k) record lists Barnstead/Thermolyne Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERILEMAX?

The FDA product code for STERILEMAX is FLE.

Related Clinical Trials

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Other records listing Barnstead/Thermolyne Corp. 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.

K014174HARVEY PV DRY STERILIZER, MODEL # ST127325; ST127320; ST127320-33

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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