STARBAND CRANIAL ORTHOSIS— 510(k) K011350

Name: FDA 510(k) clearance K011350
Creator: U.S. Food and Drug Administration
Published: 2001-07-03

Substantially Equivalent

Orthomerica Products, Inc.

FDA 510(k) clearance K011350 for STARBAND CRANIAL ORTHOSIS, Substantially Equivalent on 2001-07-03. Applicant: Orthomerica Products, Inc.. Device class: 2.

Clearance details

Applicant: Orthomerica Products, Inc.
Product code: Code OAN
Device class: Class 2
Regulation: 21 CFR 882.5970
Advisory panel: Neurology
Date received: 2001-05-02
Decision date: 2001-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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