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FDA 510(k), K192579, X-Guide Surgical Navigation System
FDA 510(k), K192579, X-Guide Surgical Navigation System
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$149.00 USD
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$149.00 USD
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510(K) Number: K192579
Device Name: X-Guide Surgical Navigation System
Manufacturer: Fred Cowdery
Device Classification Name: Dental Stereotaxic Instrument
Regulation Number: PLV
Classification Product Code: 09/19/2019
Date Received: 02/03/2020
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
Device Name: X-Guide Surgical Navigation System
Manufacturer: Fred Cowdery
Device Classification Name: Dental Stereotaxic Instrument
Regulation Number: PLV
Classification Product Code: 09/19/2019
Date Received: 02/03/2020
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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