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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
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