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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 K023572
Device Name LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDING HELMET
Applicant
Rehabilitation Institute,Loma Linda University Med
Bank One Plaza, 10 S. Dearborn
Chicago,  IL  60603
Applicant Contact LYNN D FLEISHER
Correspondent
Rehabilitation Institute,Loma Linda University Med
Bank One Plaza, 10 S. Dearborn
Chicago,  IL  60603
Correspondent Contact LYNN D FLEISHER
Regulation Number882.5970
Classification Product Code
MVA  
Date Received10/24/2002
Decision Date 01/13/2003
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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