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FDA 510(k)

STERIMASTER AUTOCLAVE

K-Number: K944036 · 1996-10-02

ApplicantScican
Decision Date1996-10-02
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERIMASTER AUTOCLAVE is the device name listed in this FDA 510(k) record. The listed applicant is Scican. It received FDA 510(k) clearance on 1996-10-02 under 510(k) number K944036. 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 STERIMASTER AUTOCLAVE?

STERIMASTER AUTOCLAVE is a medical device that received FDA 510(k) clearance on 1996-10-02. The listed applicant is Scican. The 510(k) number is K944036.

When did STERIMASTER AUTOCLAVE receive FDA 510(k) clearance?

STERIMASTER AUTOCLAVE received FDA 510(k) clearance on 1996-10-02, under 510(k) number K944036.

Who is the listed applicant for STERIMASTER AUTOCLAVE?

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

What is the FDA product code for STERIMASTER AUTOCLAVE?

The FDA product code for STERIMASTER AUTOCLAVE is FLE.

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Other records listing Scican 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.

K062418K-SPRAY, MODEL 085-2715K021064QUANTIM 16 AUTOCLAVEK983679STATIM 5000 CASSETTE AUTOCLAVEK964691TCB TEMPORARY CROWN AND BRIDGE MATERIALK962179STAT IM 5000 CASSETTE AUTOCLAVEK945142POLYSIL (VINYL POLYSILOXAN IMPRESSION MATERIAL)

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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

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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