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FDA 510(k)

MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER

K-Number: K090670 · 2009-07-07

ApplicantMidmark Corp.
Decision Date2009-07-07
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER is the device name listed in this FDA 510(k) record. The listed applicant is Midmark Corp.. It received FDA 510(k) clearance on 2009-07-07 under 510(k) number K090670. 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 MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER?

MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER is a medical device that received FDA 510(k) clearance on 2009-07-07. The listed applicant is Midmark Corp.. The 510(k) number is K090670.

When did MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER receive FDA 510(k) clearance?

MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER received FDA 510(k) clearance on 2009-07-07, under 510(k) number K090670.

Who is the listed applicant for MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER?

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

What is the FDA product code for MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER?

The FDA product code for MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER is FLE.

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Other records listing Midmark Corp. 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.

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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.

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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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