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FDA 510(k), K160713, Stealth-Midas System
FDA 510(k), K160713, Stealth-Midas System
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510(K) Number: K160713
Device Name: Stealth-Midas System
Manufacturer: DEEP PAL
Device Classification Name: Orthopedic Stereotaxic Instrument
Regulation Number: OLO
Classification Product Code: 03/15/2016
Date Received: 05/26/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: Stealth-Midas System
Manufacturer: DEEP PAL
Device Classification Name: Orthopedic Stereotaxic Instrument
Regulation Number: OLO
Classification Product Code: 03/15/2016
Date Received: 05/26/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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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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