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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 rinse, oral, antibacterial (by physical means)
De Novo Number DEN050001
510(K) Number K041482
Device Name DECAPINOL ORAL RINSE
Requester
sinclair pharmaceuticals limited
borough road
godalming,  GB
Contact michael killeen
Regulation Number872.5580
Classification Product Code
NTO  
Date Received01/24/2005
Decision Date 04/18/2005
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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