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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 St., NW
Washington,  DC  20005
Applicant Contact IVAN J WASSERMAN
Correspondent
Hanger Prosthetics & Orthotics, Inc.
700 12th St., 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
Predetermined Change
Control Plan Authorized		 No
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