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FDA 510(k), K090970, FLOCONTROL , MODEL 1028
FDA 510(k), K090970, FLOCONTROL , MODEL 1028
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510(K) Number: K090970
Device Name: FLOCONTROL , MODEL 1028
Manufacturer: SHARON D KVISTAD
Device Classification Name: Catheter, Intravascular Occluding, Temporary
Regulation Number: MJN
Classification Product Code: 04/06/2009
Date Received: 06/12/2009
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: FLOCONTROL , MODEL 1028
Manufacturer: SHARON D KVISTAD
Device Classification Name: Catheter, Intravascular Occluding, Temporary
Regulation Number: MJN
Classification Product Code: 04/06/2009
Date Received: 06/12/2009
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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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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