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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 K211376
Device Name STARband
Applicant
Orthomerica Products, Inc.
6333 N. Orange Blossom Trail
Orlando,  FL  32810
Applicant Contact David C. Kerr
Correspondent
Orthomerica Products, Inc.
6333 N. Orange Blossom Trail
Orlando,  FL  32810
Correspondent Contact Najiba Katir
Regulation Number882.5970
Classification Product Code
OAN  
Subsequent Product Code
MVA  
Date Received05/04/2021
Decision Date 08/17/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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