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FDA 510(k), K160482, t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater
FDA 510(k), K160482, t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater
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$149.00 USD
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510(K) Number: K160482
Device Name: t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater
Manufacturer: Tandem Diabetes Care, Inc.
Device Classification Name: Pump, Infusion, Insulin
Regulation Number: 880.5725
Classification Product Code: LZG
Date Received: 02/22/2016
Decision Date: 07/13/2016
Regulation Medical Specialty: General Hospital
Device Name: t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater
Manufacturer: Tandem Diabetes Care, Inc.
Device Classification Name: Pump, Infusion, Insulin
Regulation Number: 880.5725
Classification Product Code: LZG
Date Received: 02/22/2016
Decision Date: 07/13/2016
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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