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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 device, detection, sulfide
De Novo Number DEN980003
510(K) Number K980749
Device Name DIAMOND PROBE/PERIO 2000 SYSTEM
Requester
diamond general development corp.
333 parkland plaza
ann arbor,  MI  48103
Contact dale e seamon
Regulation Number872.1870
Classification Product Code
MVH  
Date Received05/18/1998
Decision Date 07/17/1998
Decision granted (DENG)
Classification Advisory Committee Dental
Review Advisory Committee Dental
Classification Order Classification Order
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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