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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
510(k) Number K022273
Device Name CRANIAL SYMMETRY SYSTEM
Applicant
Beverly Hills Prosthetics Orthotics, Inc.
6300 Wilshire Blvd., Suite 150
Los Angeles,  CA  90048
Applicant Contact KEITH E VINNECOUR
Correspondent
Beverly Hills Prosthetics Orthotics, Inc.
6300 Wilshire Blvd., Suite 150
Los Angeles,  CA  90048
Correspondent Contact KEITH E VINNECOUR
Regulation Number882.5970
Classification Product Code
MVA  
Date Received07/15/2002
Decision Date 09/09/2002
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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