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FDA 510(k), K153501, Bullfrog Micro-Infusion Device
FDA 510(k), K153501, Bullfrog Micro-Infusion Device
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510(K) Number: K153501
Device Name: Bullfrog Micro-Infusion Device
Manufacturer: MERCATOR MEDSYSTEMS, INC.
Device Classification Name: Catheter, Continuous Flush
Regulation Number: 870.1210
Classification Product Code: KRA
Date Received: 12/07/2015
Decision Date: 04/15/2016
Regulation Medical Specialty: Cardiovascular
Device Name: Bullfrog Micro-Infusion Device
Manufacturer: MERCATOR MEDSYSTEMS, INC.
Device Classification Name: Catheter, Continuous Flush
Regulation Number: 870.1210
Classification Product Code: KRA
Date Received: 12/07/2015
Decision Date: 04/15/2016
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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