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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 medication management system, remote
De Novo Number DEN060002
510(K) Number K051338
Device Name INRANGE REMOTE MEDICATION MANAGEMENT SYSTEM
Requester
inrange systems, inc.
220 lakemont park blvd.
altoona,  PA  16602
Contact christopher e bossi
Regulation Number880.6315
Classification Product Code
NZH  
Date Received09/21/2006
Decision Date 06/13/2007
Decision granted (DENG)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
Classification Order Classification Order
Type Post-NSE
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