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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
Predetermined Change
Control Plan Authorized		 No
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