FDA 510(k), K141758, T:SLIM INSULIN DELIVERY SYSTEM

FDA 510(k), K141758, T:SLIM INSULIN DELIVERY SYSTEM

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510(K) Number: K141758
Device Name: T:SLIM INSULIN DELIVERY SYSTEM
Manufacturer: TANDEM DIABETES CARE, INC.
Device Classification Name: Pump, Infusion, Insulin
Regulation Number: 880.5725
Classification Product Code: LZG
Date Received: 06/30/2014
Decision Date: 10/31/2014
Regulation Medical Specialty: General Hospital
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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