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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 K042385
Device Name DOC BAND-POSTOP
Applicant
CRANIAL TECHNOLOGIES, INC.
1395 west auto dr.
tempe,  AZ  85284
Contact timothy r littlefield
Regulation Number882.5970
Classification Product Code
MVA  
Date Received09/08/2004
Decision Date 12/17/2004
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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