BOSTON-BAND CRANIAL REMODLING ORTHOSIS— 510(k) K072862

Substantially Equivalent

Boston Brace Intl., Inc.

FDA 510(k) clearance K072862 for BOSTON-BAND CRANIAL REMODLING ORTHOSIS, Substantially Equivalent on 2008-01-22. Applicant: Boston Brace Intl., Inc..

Clearance details

Applicant: Boston Brace Intl., Inc.
Product code: Code OAN
Advisory panel: Neurology
Date received: 2007-10-05
Decision date: 2008-01-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Avon, MA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.