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FDA 510(k)

STERI-VAC GAS STERILIZER MODEL 8XL

K-Number: K941748 · 1994-12-02

Applicant3M Health Care, Ltd.
Decision Date1994-12-02
Product CodeFLF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERI-VAC GAS STERILIZER MODEL 8XL is the device name listed in this FDA 510(k) record. The listed applicant is 3M Health Care, Ltd.. It received FDA 510(k) clearance on 1994-12-02 under 510(k) number K941748. 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 STERI-VAC GAS STERILIZER MODEL 8XL?

STERI-VAC GAS STERILIZER MODEL 8XL is a medical device that received FDA 510(k) clearance on 1994-12-02. The listed applicant is 3M Health Care, Ltd.. The 510(k) number is K941748.

When did STERI-VAC GAS STERILIZER MODEL 8XL receive FDA 510(k) clearance?

STERI-VAC GAS STERILIZER MODEL 8XL received FDA 510(k) clearance on 1994-12-02, under 510(k) number K941748.

Who is the listed applicant for STERI-VAC GAS STERILIZER MODEL 8XL?

The FDA 510(k) record lists 3M Health Care, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERI-VAC GAS STERILIZER MODEL 8XL?

The FDA product code for STERI-VAC GAS STERILIZER MODEL 8XL is FLF.

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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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