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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 K063133
Device Name CRANIAL SOLUTION ORTHOSIS
Applicant
CRANIAL SOLUTIONS
602 LINCOLN AVE.
pompton lakes,  NJ  07442
Applicant Contact kirk a lucyk
Correspondent
CRANIAL SOLUTIONS
602 LINCOLN AVE.
pompton lakes,  NJ  07442
Correspondent Contact kirk a lucyk
Regulation Number882.5970
Classification Product Code
MVA  
Date Received10/13/2006
Decision Date 07/02/2007
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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