MICHIGAN CRANIAL RESHAPING ORTHOSIS— 510(k) K090341

Name: FDA 510(k) clearance K090341
Creator: U.S. Food and Drug Administration
Published: 2010-01-06

Substantially Equivalent

Danmar Products, Inc.

FDA 510(k) clearance K090341 for MICHIGAN CRANIAL RESHAPING ORTHOSIS, Substantially Equivalent on 2010-01-06. Applicant: Danmar Products, Inc.. Device class: 2.

Clearance details

Applicant: Danmar Products, Inc.
Product code: Code MVA
Device class: Class 2
Regulation: 21 CFR 882.5970
Advisory panel: Neurology
Date received: 2009-02-10
Decision date: 2010-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dearborn, MI, US

Download summary PDF View on FDA.gov ↗

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