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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

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Device Classification Name orthosis, cranial
De Novo Number DEN980001
510(K) Number K964992
Device Name DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC BAND
Requester
cranial technologies, inc.
1331 north 7th st., suite 170
phoenix,  AZ  85006
Contact timothy r littlefield
Regulation Number882.5970
Classification Product Code
MVA  
Date Received03/31/1998
Decision Date 05/29/1998
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Classification Order Classification Order
Type Post-NSE
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