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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 implantable radio frequency transponder system
De Novo Number DEN040007
510(K) Number K033440
Device Name VERICHIP HEALTH INFORMATION MICROTRANSPONDER AND POCKET READER
Requester
digital angel corporation
490 villaume ave.
south st. paul,  MN  55075
Contact kevin mclaughlin
Regulation Number880.6300
Classification Product Code
NRV  
Date Received08/04/2004
Decision Date 10/12/2004
Decision granted (DENG)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
Classification Order Classification Order
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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