HANGER CRANIAL BAND— 510(k) K072566

Name: FDA 510(k) clearance K072566
Creator: U.S. Food and Drug Administration
Published: 2008-01-09

Substantially Equivalent

Hanger Prosthetics & Orthotics, Inc.

FDA 510(k) clearance K072566 for HANGER CRANIAL BAND, Substantially Equivalent on 2008-01-09. Applicant: Hanger Prosthetics & Orthotics, Inc.. Device class: 2.

Clearance details

Applicant: Hanger Prosthetics & Orthotics, Inc.
Product code: Code OAN
Device class: Class 2
Regulation: 21 CFR 882.5970
Advisory panel: Neurology
Date received: 2007-09-12
Decision date: 2008-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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