FDA 510(k) Application Details - DEN050001

Device Classification Name Rinse, Oral, Antibacterial (By Physical Means)

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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
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Regulation Number 872.5580

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Classification Product Code NTO
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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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