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FDA 510(k), K100947, FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000
FDA 510(k), K100947, FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000
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510(K) Number: K100947
Device Name: FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000
Manufacturer: CALIBRA MEDICAL, INC.
Device Classification Name: pump, infusion, insulin bolus
Regulation Number: 880.5725
Classification Product Code: OPP
Date Received: 04/06/2010
Decision Date: 06/28/2010
Regulation Medical Specialty: General Hospital
Device Name: FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000
Manufacturer: CALIBRA MEDICAL, INC.
Device Classification Name: pump, infusion, insulin bolus
Regulation Number: 880.5725
Classification Product Code: OPP
Date Received: 04/06/2010
Decision Date: 06/28/2010
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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