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FDA 510(k)

RESUBMITTED STC SERIES 8600 AUTOCLAVE

K-Number: K890359 · 1989-08-07

ApplicantSterilizer Technologies Corp.
Decision Date1989-08-07
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

RESUBMITTED STC SERIES 8600 AUTOCLAVE is the device name listed in this FDA 510(k) record. The listed applicant is Sterilizer Technologies Corp.. It received FDA 510(k) clearance on 1989-08-07 under 510(k) number K890359. 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 RESUBMITTED STC SERIES 8600 AUTOCLAVE?

RESUBMITTED STC SERIES 8600 AUTOCLAVE is a medical device that received FDA 510(k) clearance on 1989-08-07. The listed applicant is Sterilizer Technologies Corp.. The 510(k) number is K890359.

When did RESUBMITTED STC SERIES 8600 AUTOCLAVE receive FDA 510(k) clearance?

RESUBMITTED STC SERIES 8600 AUTOCLAVE received FDA 510(k) clearance on 1989-08-07, under 510(k) number K890359.

Who is the listed applicant for RESUBMITTED STC SERIES 8600 AUTOCLAVE?

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

What is the FDA product code for RESUBMITTED STC SERIES 8600 AUTOCLAVE?

The FDA product code for RESUBMITTED STC SERIES 8600 AUTOCLAVE is FLE.

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Other records listing Sterilizer Technologies 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.

K904112STI DRAPE SHEET STYLE 1908

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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