BOSTON BAND


Device Classification Name

orthosis, cranial

510(k) Number K111609
Device Name BOSTON BAND
Applicant
BOSTON BRACE INTL., INC.
20 ledin dr.
avon, 
MA 
02322

Applicant Contact james wynne
Correspondent
BOSTON BRACE INTL., INC.
20 ledin dr.
avon, 
MA 
02322

Correspodent Contact james wynne
Regulation Number 882.5970
Classification Product Code
MVA  
Date Received 06/09/2011
Decision Date 08/22/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No