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FDA 510(k), K121057, COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS
FDA 510(k), K121057, COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS
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510(K) Number: K121057
Device Name: COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS
Manufacturer: Jennifer Brown
Device Classification Name: Filter, Intravascular, Cardiovascular
Regulation Number: DTK
Classification Product Code: 04/06/2012
Date Received: 05/04/2012
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS
Manufacturer: Jennifer Brown
Device Classification Name: Filter, Intravascular, Cardiovascular
Regulation Number: DTK
Classification Product Code: 04/06/2012
Date Received: 05/04/2012
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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