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FDA 510(k)

MEDIFLASH AND ESTEFLASH

K-Number: K093168 · 2010-05-21

ApplicantDermeo
Decision Date2010-05-21
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDIFLASH AND ESTEFLASH is the device name listed in this FDA 510(k) record. The listed applicant is Dermeo. It received FDA 510(k) clearance on 2010-05-21 under 510(k) number K093168. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDIFLASH AND ESTEFLASH?

MEDIFLASH AND ESTEFLASH is a medical device that received FDA 510(k) clearance on 2010-05-21. The listed applicant is Dermeo. The 510(k) number is K093168.

When did MEDIFLASH AND ESTEFLASH receive FDA 510(k) clearance?

MEDIFLASH AND ESTEFLASH received FDA 510(k) clearance on 2010-05-21, under 510(k) number K093168.

Who is the listed applicant for MEDIFLASH AND ESTEFLASH?

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

What is the FDA product code for MEDIFLASH AND ESTEFLASH?

The FDA product code for MEDIFLASH AND ESTEFLASH is ONF.

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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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