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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
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
Correspondent Contact JAMES WYNNE
Regulation Number882.5970
Classification Product Code
MVA  
Date Received06/09/2011
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
Predetermined Change
Control Plan Authorized		 No
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