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FDA 510(k), K083641, BIVONA TRACHEOSTOMY TUBES
FDA 510(k), K083641, BIVONA TRACHEOSTOMY TUBES
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510(K) Number: K083641
Device Name: BIVONA TRACHEOSTOMY TUBES
Manufacturer: SMITHS MEDICAL ASD, INC.
Device Classification Name: tube tracheostomy and tube cuff
Regulation Number: 868.5800
Classification Product Code: JOH
Date Received: 12/09/2008
Decision Date: 02/23/2009
Regulation Medical Specialty: Anesthesiology
Device Name: BIVONA TRACHEOSTOMY TUBES
Manufacturer: SMITHS MEDICAL ASD, INC.
Device Classification Name: tube tracheostomy and tube cuff
Regulation Number: 868.5800
Classification Product Code: JOH
Date Received: 12/09/2008
Decision Date: 02/23/2009
Regulation Medical Specialty: Anesthesiology
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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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