CCRO (CRANIOCEPHALIC CUSTOM REMOLDING ORTHOSIS)— 510(k) K070694

Name: FDA 510(k) clearance K070694
Creator: U.S. Food and Drug Administration
Published: 2007-09-10

Substantially Equivalent

Mike Miner

FDA 510(k) clearance K070694 for CCRO (CRANIOCEPHALIC CUSTOM REMOLDING ORTHOSIS), Substantially Equivalent on 2007-09-10. Applicant: Mike Miner. Device class: 2.

Clearance details

Applicant: Mike Miner
Product code: Code MVA
Device class: Class 2
Regulation: 21 CFR 882.5970
Advisory panel: Neurology
Date received: 2007-03-13
Decision date: 2007-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kaysville, UT, US

Download summary PDF View on FDA.gov ↗

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