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FDA 510(k), K160056, t:slim Insulin Delivery System
FDA 510(k), K160056, t:slim Insulin Delivery System
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$149.00 USD
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510(K) Number: K160056
Device Name: t:slim Insulin Delivery System
Manufacturer: Michael Sarrasin
Device Classification Name: Pump, Infusion, Insulin
Regulation Number: LZG
Classification Product Code: KXA
Date Received: 01/12/2016
Decision Date: 07/25/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: t:slim Insulin Delivery System
Manufacturer: Michael Sarrasin
Device Classification Name: Pump, Infusion, Insulin
Regulation Number: LZG
Classification Product Code: KXA
Date Received: 01/12/2016
Decision Date: 07/25/2016
Decision: Substantially Equivalent (SESE)
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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