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FDA 510(k)

MN-111

K-Number: K172825 · 2018-05-30

ApplicantW&H Sterilization S.R.L.
Decision Date2018-05-30
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MN-111 is the device name listed in this FDA 510(k) record. The listed applicant is W&H Sterilization S.R.L.. It received FDA 510(k) clearance on 2018-05-30 under 510(k) number K172825. 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 MN-111?

MN-111 is a medical device that received FDA 510(k) clearance on 2018-05-30. The listed applicant is W&H Sterilization S.R.L.. The 510(k) number is K172825.

When did MN-111 receive FDA 510(k) clearance?

MN-111 received FDA 510(k) clearance on 2018-05-30, under 510(k) number K172825.

Who is the listed applicant for MN-111?

The FDA 510(k) record lists W&H Sterilization S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MN-111?

The FDA product code for MN-111 is FLE.

Other records listing W&H Sterilization S.R.L. 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.

K233504Lexa MINI (RIS-303, RIS-305)K223858Lexa MINI (RIS-303, RIS-305)K213758Lexa PLUS RIS-311

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

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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