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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 K103362
Device Name AOI CRANIAL HELMET
Applicant
ADVANCED ORTHOPRO INC.
1820 N. ILLINOIS ST.
INDIANAPOLIS,  IN  46202
Applicant Contact MOHAMAD MANSOORI
Correspondent
ADVANCED ORTHOPRO INC.
1820 N. ILLINOIS ST.
INDIANAPOLIS,  IN  46202
Correspondent Contact MOHAMAD MANSOORI
Regulation Number882.5970
Classification Product Code
MVA  
Date Received11/17/2010
Decision Date 04/18/2011
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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