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FDA 510(k), K111210, T:SLIM (TM) INSULIN DELIVERY SYSTEM
FDA 510(k), K111210, T:SLIM (TM) INSULIN DELIVERY SYSTEM
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510(K) Number: K111210
Device Name: T:SLIM (TM) INSULIN DELIVERY SYSTEM
Manufacturer: TANDEM DIABETES CARE, INC.
Device Classification Name: pump, infusion, insulin
Regulation Number: 880.5725
Classification Product Code: LZG
Date Received: 04/29/2011
Decision Date: 11/09/2011
Regulation Medical Specialty: General Hospital
Device Name: T:SLIM (TM) INSULIN DELIVERY SYSTEM
Manufacturer: TANDEM DIABETES CARE, INC.
Device Classification Name: pump, infusion, insulin
Regulation Number: 880.5725
Classification Product Code: LZG
Date Received: 04/29/2011
Decision Date: 11/09/2011
Regulation Medical Specialty: General Hospital
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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