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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 K082945
Device Name STARLIGHT
Applicant
ORTHOMERICA PRODUCTS, INC.
6333 NORTH ORANGE BLOSSOM
TRAIL
ORLANDO,  FL  32810
Applicant Contact ALAN T SANDIFER
Correspondent
ORTHOMERICA PRODUCTS, INC.
6333 NORTH ORANGE BLOSSOM
TRAIL
ORLANDO,  FL  32810
Correspondent Contact ALAN T SANDIFER
Regulation Number882.5970
Classification Product Code
OAN  
Subsequent Product Code
MVA  
Date Received10/02/2008
Decision Date 10/31/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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