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FDA 510(k)

ARS ENTERPRISES NEW/REMFR'D GP STEAM STERILIZER 81

K-Number: K852113 · 1985-09-27

ApplicantArs Enterprises, Inc.
Decision Date1985-09-27
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ARS ENTERPRISES NEW/REMFR'D GP STEAM STERILIZER 81 is the device name listed in this FDA 510(k) record. The listed applicant is Ars Enterprises, Inc.. It received FDA 510(k) clearance on 1985-09-27 under 510(k) number K852113. 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 ARS ENTERPRISES NEW/REMFR'D GP STEAM STERILIZER 81?

ARS ENTERPRISES NEW/REMFR'D GP STEAM STERILIZER 81 is a medical device that received FDA 510(k) clearance on 1985-09-27. The listed applicant is Ars Enterprises, Inc.. The 510(k) number is K852113.

When did ARS ENTERPRISES NEW/REMFR'D GP STEAM STERILIZER 81 receive FDA 510(k) clearance?

ARS ENTERPRISES NEW/REMFR'D GP STEAM STERILIZER 81 received FDA 510(k) clearance on 1985-09-27, under 510(k) number K852113.

Who is the listed applicant for ARS ENTERPRISES NEW/REMFR'D GP STEAM STERILIZER 81?

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

What is the FDA product code for ARS ENTERPRISES NEW/REMFR'D GP STEAM STERILIZER 81?

The FDA product code for ARS ENTERPRISES NEW/REMFR'D GP STEAM STERILIZER 81 is FLE.

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Other records listing Ars Enterprises, 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.

K852115ARS ENTERPRISES ETHYLENE OXIDE GAS STERILIZERK852114ARS ENTERPRISES PRE-VACUUM STEAM STERILIZER 85000K831356STEAM STERILIZER

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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