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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact JAMES H WYNNE
Regulation Number882.5970
Classification Product Code
OAN  
Subsequent Product Code
MVA  
Date Received10/05/2007
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
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