FDA 510(k), K981095, ALIGN SYSTEM
FDA 510(k), K981095, ALIGN SYSTEM
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510(K) Number: K981095
Device Name: ALIGN SYSTEM
Manufacturer: ALIGN TECHNOLOGY
Device Classification Name: Aligner, Sequential
Regulation Number: 872.5470
Classification Product Code: NXC
Date Received: 03/26/1998
Decision Date: 09/08/1998
Regulation Medical Specialty: Dental
Device Name: ALIGN SYSTEM
Manufacturer: ALIGN TECHNOLOGY
Device Classification Name: Aligner, Sequential
Regulation Number: 872.5470
Classification Product Code: NXC
Date Received: 03/26/1998
Decision Date: 09/08/1998
Regulation Medical Specialty: Dental
- 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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