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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 K072566
Device Name HANGER CRANIAL BAND
Applicant
HANGER PROSTHETICS & ORTHOTICS, INC.
700 12TH STREET, NW
WASHINGTON,  DC  20005
Applicant Contact IVAN J WASSERMAN
Correspondent
HANGER PROSTHETICS & ORTHOTICS, INC.
700 12TH STREET, NW
WASHINGTON,  DC  20005
Correspondent Contact IVAN J WASSERMAN
Regulation Number882.5970
Classification Product Code
OAN  
Subsequent Product Code
MVA  
Date Received09/12/2007
Decision Date 01/09/2008
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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