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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name rinse, oral, antibacterial (by physical means)
510(k) Number K041482
Device Name DECAPINOL ORAL RINSE
Original Applicant
SINCLAIR PHARMACEUTICALS LIMITED
borough road
godalming,  UK
Original Contact michael killeen
Regulation Number872.5580
Classification Product Code
NTO  
Date Received06/11/2004
Decision Date 04/18/2005
Decision de novo petitions granted (AN)
Classification Advisory Committee Dental
Review Advisory Committee Dental
FOI Item Approval Letter
Type De Novo Petitions Granted
Reviewed by Third Party No
Expedited Review No
Combination Product No
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