CRANIAL SOLUTION ORTHOSIS— 510(k) K063133

Substantially Equivalent

Cranial Solutions

FDA 510(k) clearance K063133 for CRANIAL SOLUTION ORTHOSIS, Substantially Equivalent on 2007-07-02. Applicant: Cranial Solutions. Device class: 2.

Clearance details

Applicant: Cranial Solutions
Product code: Code MVA
Device class: Class 2
Regulation: 21 CFR 882.5970
Advisory panel: Neurology
Date received: 2006-10-13
Decision date: 2007-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pompton Lakes, NJ, 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.