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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 K124023
Device Name STARBAND
Applicant
ORTHOMERICA PRODUCTS, INC.
6333 N Orange Blossom Trl
ORLANDO,  FL  32810
Applicant Contact DAVID L HOOPER
Correspondent
ORTHOMERICA PRODUCTS, INC.
6333 N Orange Blossom Trl
ORLANDO,  FL  32810
Correspondent Contact DAVID L HOOPER
Regulation Number882.5970
Classification Product Code
OAN  
Date Received12/28/2012
Decision Date 06/10/2013
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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