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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 K151147
Device Name STARband, STARlight
Applicant
ORTHOMERICA PRODUCTS, INC.
6333 NORTH ORANGE BLOSSOM TRAIL
ORLANDO,  FL  32810
Applicant Contact DAVID C. KERR
Correspondent
ORTHOMERICA PRODUCTS, INC.
6333 NORTH ORANGE BLOSSOM TRAIL
ORLANDO,  FL  32810
Correspondent Contact DAVID L. HOOPER
Regulation Number882.5970
Classification Product Code
OAN  
Subsequent Product Code
MVA  
Date Received04/30/2015
Decision Date 07/01/2015
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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