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FDA 510(k), K200348, Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)
FDA 510(k), K200348, Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)
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510(K) Number: K200348
Device Name: Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)
Manufacturer: Neocis Inc.
Device Classification Name: Dental Stereotaxic Instrument
Regulation Number: 872.4120
Classification Product Code: PLV
Date Received: 02/12/2020
Decision Date: 05/08/2020
Regulation Medical Specialty: Dental
Device Name: Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)
Manufacturer: Neocis Inc.
Device Classification Name: Dental Stereotaxic Instrument
Regulation Number: 872.4120
Classification Product Code: PLV
Date Received: 02/12/2020
Decision Date: 05/08/2020
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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