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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 N. Orange Blossom Trl.
Orlando,  FL  32810
Applicant Contact ALAN T SANDIFER
Correspondent
Orthomerica Products, Inc.
6333 N. Orange Blossom Trl.
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
Predetermined Change
Control Plan Authorized		 No
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