MICHIGAN CRANIAL RESHAPING ORTHOSIS— 510(k) K090341

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..

Clearance details

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

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