BOSTON BAND— 510(k) K111609

Substantially Equivalent

Boston Brace Intl., Inc.

FDA 510(k) clearance K111609 for BOSTON BAND, Substantially Equivalent on 2011-08-22. Applicant: Boston Brace Intl., Inc.. Device class: 2.

Clearance details

Applicant: Boston Brace Intl., Inc.
Product code: Code MVA
Device class: Class 2
Regulation: 21 CFR 882.5970
Advisory panel: Neurology
Date received: 2011-06-09
Decision date: 2011-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Avon, MA, US

Download summary PDF View on FDA.gov ↗

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