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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 K063395
Device Name O&P BIVALVE CRANIAL MOLDING HELMET
Applicant
Orthotic & Prosthetic Lab, Inc.
748 Marshall Ave.
Webster Groves,  MO  63119
Applicant Contact THOMAS L MALONE
Correspondent
Orthotic & Prosthetic Lab, Inc.
748 Marshall Ave.
Webster Groves,  MO  63119
Correspondent Contact THOMAS L MALONE
Regulation Number882.5970
Classification Product Code
MVA  
Date Received11/09/2006
Decision Date 12/22/2006
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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