STATIC CRANIOPLASTY ORTHOSIS— 510(k) K063098

Name: FDA 510(k) clearance K063098
Creator: U.S. Food and Drug Administration
Published: 2007-04-11

Substantially Equivalent

Boston Brace Intl., Inc.

FDA 510(k) clearance K063098 for STATIC CRANIOPLASTY ORTHOSIS, Substantially Equivalent on 2007-04-11. Applicant: Boston Brace Intl., Inc.. Device class: 2.

Clearance details

Applicant: Boston Brace Intl., Inc.
Product code: Code OAN
Device class: Class 2
Regulation: 21 CFR 882.5970
Advisory panel: Neurology
Date received: 2006-10-10
Decision date: 2007-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Avon, MA, US

Download summary PDF View on FDA.gov ↗

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