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FDA 510(k)

ARS ENTERPRISES ETHYLENE OXIDE GAS STERILIZER

K-Number: K852115 · 1985-11-01

ApplicantArs Enterprises, Inc.
Decision Date1985-11-01
Product CodeFLF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ARS ENTERPRISES ETHYLENE OXIDE GAS STERILIZER 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 1985-11-01 under 510(k) number K852115. The device is classified under product code FLF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARS ENTERPRISES ETHYLENE OXIDE GAS STERILIZER?

ARS ENTERPRISES ETHYLENE OXIDE GAS STERILIZER is a medical device that received FDA 510(k) clearance on 1985-11-01. The listed applicant is Ars Enterprises, Inc.. The 510(k) number is K852115.

When did ARS ENTERPRISES ETHYLENE OXIDE GAS STERILIZER receive FDA 510(k) clearance?

ARS ENTERPRISES ETHYLENE OXIDE GAS STERILIZER received FDA 510(k) clearance on 1985-11-01, under 510(k) number K852115.

Who is the listed applicant for ARS ENTERPRISES ETHYLENE OXIDE GAS STERILIZER?

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 ETHYLENE OXIDE GAS STERILIZER?

The FDA product code for ARS ENTERPRISES ETHYLENE OXIDE GAS STERILIZER is FLF.

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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.

K852113ARS ENTERPRISES NEW/REMFR'D GP STEAM STERILIZER 81K852114ARS ENTERPRISES PRE-VACUUM STEAM STERILIZER 85000K831356STEAM STERILIZER

Related Devices (Code: FLF)

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.

K192978EOGas 4 Ethylene Oxide Gas SterilizerAndersen Sterilizers, Inc.K170432Anprolene AN75 Ethylene Oxide Gas SterilizerAndersen Sterilizers, Inc.K090636TSO3 OZONE STERILIZER, MODEL 125LTso3, Inc.K051595TSO3 OZONE STERILIZER, MODEL 125LTso3, Inc.K020875TSO3 OZONE STERILIZER, MODEL 125LTechnologies of Sterilization With Oxone, Tso3, Inc.K014013H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEMH & W Technology, LLC

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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