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FDA 510(k), K143630, Invisalign System
FDA 510(k), K143630, Invisalign System
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$149.00 USD
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510(K) Number: K143630
Device Name: Invisalign System
Manufacturer: ALIGN TECHNOLOGY, INC.
Device Classification Name: aligner, sequential
Regulation Number: 872.5470
Classification Product Code: NXC
Date Received: 12/22/2014
Decision Date: 11/18/2015
Regulation Medical Specialty: Dental
Device Name: Invisalign System
Manufacturer: ALIGN TECHNOLOGY, INC.
Device Classification Name: aligner, sequential
Regulation Number: 872.5470
Classification Product Code: NXC
Date Received: 12/22/2014
Decision Date: 11/18/2015
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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