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FDA 510(k)

STEAM STERILIZER (AUTOCLAVE), DENTAL

K-Number: K895638 · 1990-02-22

ApplicantPorter Instrument Co., Inc.
Decision Date1990-02-22
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STEAM STERILIZER (AUTOCLAVE), DENTAL is the device name listed in this FDA 510(k) record. The listed applicant is Porter Instrument Co., Inc.. It received FDA 510(k) clearance on 1990-02-22 under 510(k) number K895638. 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 STEAM STERILIZER (AUTOCLAVE), DENTAL?

STEAM STERILIZER (AUTOCLAVE), DENTAL is a medical device that received FDA 510(k) clearance on 1990-02-22. The listed applicant is Porter Instrument Co., Inc.. The 510(k) number is K895638.

When did STEAM STERILIZER (AUTOCLAVE), DENTAL receive FDA 510(k) clearance?

STEAM STERILIZER (AUTOCLAVE), DENTAL received FDA 510(k) clearance on 1990-02-22, under 510(k) number K895638.

Who is the listed applicant for STEAM STERILIZER (AUTOCLAVE), DENTAL?

The FDA 510(k) record lists Porter Instrument Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STEAM STERILIZER (AUTOCLAVE), DENTAL?

The FDA product code for STEAM STERILIZER (AUTOCLAVE), DENTAL is FLE.

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Other records listing Porter Instrument Co., 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.

K062155DIGITAL MXR-D FLOWMETERK981754AUTOMATIC VACUUM SWITCH (AVS) MODEL NUMBER AVS 5000K924596SES-2012 AUTOMATIC STEAM STERILIZERK923781MXR-2000 FLOWMETERK802067CLEAN-AIR POLLUTION REDUCTION SYSTEM

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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