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FDA 510(k), K093821, FS ALIGNER
FDA 510(k), K093821, FS ALIGNER
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510(K) Number: K093821
Device Name: FS ALIGNER
Manufacturer: ALLESEE ORTHODONTIC APPLIANCES
Device Classification Name: aligner, sequential
Regulation Number: 872.5470
Classification Product Code: NXC
Date Received: 12/14/2009
Decision Date: 08/27/2010
Regulation Medical Specialty: Dental
Device Name: FS ALIGNER
Manufacturer: ALLESEE ORTHODONTIC APPLIANCES
Device Classification Name: aligner, sequential
Regulation Number: 872.5470
Classification Product Code: NXC
Date Received: 12/14/2009
Decision Date: 08/27/2010
Regulation Medical Specialty: Dental
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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