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FDA 510(k) Application Details - DEN050001
Device Classification Name
Rinse, Oral, Antibacterial (By Physical Means)
More FDA Info for this Device
510(K) Number
DEN050001
Device Name
Rinse, Oral, Antibacterial (By Physical Means)
Applicant
SINCLAIR PHARMACEUTICALS LIMITED
BOROUGH ROAD
GODALMING GB
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Contact
MICHAEL KILLEEN
Other 510(k) Applications for this Contact
Regulation Number
872.5580
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Classification Product Code
NTO
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More FDA Info for this Product Code
Date Received
01/24/2005
Decision Date
04/18/2005
Decision
DENG -
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Type
Post-NSE
Reviewed By Third Party
N
Expedited Review
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