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FDA 510(k), K083597, SONOWAND INVITE
FDA 510(k), K083597, SONOWAND INVITE
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510(K) Number: K083597
Device Name: SONOWAND INVITE
Manufacturer: SONOWAND AS
Device Classification Name: neurological stereotaxic instrument
Regulation Number: 882.4560
Classification Product Code: HAW
Date Received: 12/05/2008
Decision Date: 09/25/2009
Regulation Medical Specialty: Neurology
Device Name: SONOWAND INVITE
Manufacturer: SONOWAND AS
Device Classification Name: neurological stereotaxic instrument
Regulation Number: 882.4560
Classification Product Code: HAW
Date Received: 12/05/2008
Decision Date: 09/25/2009
Regulation Medical Specialty: Neurology
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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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