BOSTON-BAND CRANIAL REMODLING ORTHOSIS


Device Classification Name

orthosis, cranial, laser scan

510(k) Number K072862
Device Name BOSTON-BAND CRANIAL REMODLING ORTHOSIS
Applicant
BOSTON BRACE INTL., INC.
20 ledin dr.
avon, 
MA 
02322

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

Correspodent Contact james h wynne
Regulation Number 882.5970
Classification Product Code
OAN  
Subsequent Product Code
MVA  
Date Received 10/05/2007
Decision Date 01/22/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No