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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 K013719
Device Name BECKER BAND CRANIAL REMOLDING ORTHOSIS
Applicant
BECKER ORTHOPEDIC APPLIANCE CO.
635 EXECUTIVE DR.
TROY,  MI  48083
Applicant Contact JAMES H CAMPBELL
Correspondent
BECKER ORTHOPEDIC APPLIANCE CO.
635 EXECUTIVE DR.
TROY,  MI  48083
Correspondent Contact JAMES H CAMPBELL
Regulation Number882.5970
Classification Product Code
MVA  
Date Received11/08/2001
Decision Date 02/05/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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