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FDA 510(k)

THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER

K-Number: K931872 · 1994-02-07

ApplicantAmerican Sterilizer Co.
Decision Date1994-02-07
Product CodeFLF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER is the device name listed in this FDA 510(k) record. The listed applicant is American Sterilizer Co.. It received FDA 510(k) clearance on 1994-02-07 under 510(k) number K931872. 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 THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER?

THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER is a medical device that received FDA 510(k) clearance on 1994-02-07. The listed applicant is American Sterilizer Co.. The 510(k) number is K931872.

When did THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER receive FDA 510(k) clearance?

THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER received FDA 510(k) clearance on 1994-02-07, under 510(k) number K931872.

Who is the listed applicant for THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER?

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

What is the FDA product code for THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER?

The FDA product code for THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER is FLF.

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Other records listing American Sterilizer Co. 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.

K943288AMSCO SQ240 SURGICAL LIGHTK922485CHEMDI-VHP CHEMICAL INDICATORK930493QUANTUM 3080 SURGICAL TABLEK905816ORTHOVISION TABLEK896674AMSCO QUANTUM LIGHTK895164EAGLE DS

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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

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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