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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 K063098
Device Name STATIC CRANIOPLASTY ORTHOSIS
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
Correspondent Contact JAMES WYNNE
Regulation Number882.5970
Classification Product Code
OAN  
Date Received10/10/2006
Decision Date 04/11/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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