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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 K161138
Device Name St. Louis Band
Applicant
Orthomerica Products, Inc.
6333 N. Orange Blossom Trl.
Orlando,  FL  32810
Applicant Contact DAVID C. KERR
Correspondent
Orthomerica Products, Inc.
6333 N. Orange Blossom Trl.
Orlando,  FL  32810
Correspondent Contact DAVID L. HOOPER
Regulation Number882.5970
Classification Product Code
OAN  
Subsequent Product Code
MVA  
Date Received04/22/2016
Decision Date 07/20/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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