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FDA 510(k), K133573, FIAGON NAVIGATION SYSTEM
FDA 510(k), K133573, FIAGON NAVIGATION SYSTEM
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510(K) Number: K133573
Device Name: FIAGON NAVIGATION SYSTEM
Manufacturer: DIRK MUCHA
Device Classification Name: Ear, Nose, And Throat Stereotaxic Instrument
Regulation Number: PGW
Classification Product Code: 11/20/2013
Date Received: 04/30/2014
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ear Nose & Throat
Device Name: FIAGON NAVIGATION SYSTEM
Manufacturer: DIRK MUCHA
Device Classification Name: Ear, Nose, And Throat Stereotaxic Instrument
Regulation Number: PGW
Classification Product Code: 11/20/2013
Date Received: 04/30/2014
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ear Nose & Throat
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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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