ACTHYDERM— 510(k) K083016

Substantially Equivalent

Microlab Americas, Inc.

FDA 510(k) clearance K083016 for ACTHYDERM, Substantially Equivalent on 2009-06-16. Applicant: Microlab Americas, Inc.. Device class: 2.

Clearance details

Applicant: Microlab Americas, Inc.
Product code: Code EGJ
Device class: Class 2
Regulation: 21 CFR 890.5525
Advisory panel: Physical Medicine
Date received: 2008-10-09
Decision date: 2009-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crofton, MD, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.