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FDA 510(k)

PRIMUS STEAM STERILIZERS

K-Number: K991575 · 1999-12-03

ApplicantPrimus Sterilizer Co., Inc.
Decision Date1999-12-03
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PRIMUS STEAM STERILIZERS is the device name listed in this FDA 510(k) record. The listed applicant is Primus Sterilizer Co., Inc.. It received FDA 510(k) clearance on 1999-12-03 under 510(k) number K991575. 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 PRIMUS STEAM STERILIZERS?

PRIMUS STEAM STERILIZERS is a medical device that received FDA 510(k) clearance on 1999-12-03. The listed applicant is Primus Sterilizer Co., Inc.. The 510(k) number is K991575.

When did PRIMUS STEAM STERILIZERS receive FDA 510(k) clearance?

PRIMUS STEAM STERILIZERS received FDA 510(k) clearance on 1999-12-03, under 510(k) number K991575.

Who is the listed applicant for PRIMUS STEAM STERILIZERS?

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

What is the FDA product code for PRIMUS STEAM STERILIZERS?

The FDA product code for PRIMUS STEAM STERILIZERS 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.

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Other records listing Primus Sterilizer 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.

K926185PRIMUS PSS SERIES STERILIZERS

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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