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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 K001669
Device Name HANGER CRANIAL BAND
Applicant
HANGER ORTHOPEDIC GROUP, INC.
2 Bethesda Metro Center
Bethesda,  MD  20814
Applicant Contact JOSEPH MCTERNAN
Correspondent
HANGER ORTHOPEDIC GROUP, INC.
2 Bethesda Metro Center
Bethesda,  MD  20814
Correspondent Contact JOSEPH MCTERNAN
Regulation Number882.5970
Classification Product Code
MVA  
Date Received05/31/2000
Decision Date 12/08/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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