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FDA 510(k), K053166, SINCLAIR ORAL RINSE
FDA 510(k), K053166, SINCLAIR ORAL RINSE
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510(K) Number: K053166
Device Name: SINCLAIR ORAL RINSE
Manufacturer: MICHAEL KILLEEN
Device Classification Name: Rinse, Oral, Antibacterial (By Physical Means)
Regulation Number: NTO
Classification Product Code: 11/14/2005
Date Received: 05/17/2006
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
Device Name: SINCLAIR ORAL RINSE
Manufacturer: MICHAEL KILLEEN
Device Classification Name: Rinse, Oral, Antibacterial (By Physical Means)
Regulation Number: NTO
Classification Product Code: 11/14/2005
Date Received: 05/17/2006
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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