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FDA 510(k)

ACTHYDERM

K-Number: K083016 · 2009-06-16

ApplicantMicrolab Americas, Inc.
Decision Date2009-06-16
Product CodeEGJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ACTHYDERM is the device name listed in this FDA 510(k) record. The listed applicant is Microlab Americas, Inc.. It received FDA 510(k) clearance on 2009-06-16 under 510(k) number K083016. The device is classified under product code EGJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACTHYDERM?

ACTHYDERM is a medical device that received FDA 510(k) clearance on 2009-06-16. The listed applicant is Microlab Americas, Inc.. The 510(k) number is K083016.

When did ACTHYDERM receive FDA 510(k) clearance?

ACTHYDERM received FDA 510(k) clearance on 2009-06-16, under 510(k) number K083016.

Who is the listed applicant for ACTHYDERM?

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

What is the FDA product code for ACTHYDERM?

The FDA product code for ACTHYDERM is EGJ.

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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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