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FDA 510(k), K143189, t:flex Insulin Delivery System
FDA 510(k), K143189, t:flex Insulin Delivery System
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$149.00 USD
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510(K) Number: K143189
Device Name: t:flex Insulin Delivery System
Manufacturer: Tandem Diabetes Care, Inc.
Device Classification Name: pump, infusion, insulin
Regulation Number: 880.5725
Classification Product Code: LZG
Date Received: 11/05/2014
Decision Date: 01/09/2015
Regulation Medical Specialty: General Hospital
Device Name: t:flex Insulin Delivery System
Manufacturer: Tandem Diabetes Care, Inc.
Device Classification Name: pump, infusion, insulin
Regulation Number: 880.5725
Classification Product Code: LZG
Date Received: 11/05/2014
Decision Date: 01/09/2015
Regulation Medical Specialty: General Hospital
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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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