FDA 510(k) Applications for Medical Device Product Code "OPP"
(Pump, Infusion, Insulin Bolus)

FDA 510(k) Number Applicant Device Name Decision Date
K111924 CALIBRA MEDICAL, INC. FINESSE PERSONAL INSULIN DELIVERY PATCH 04/10/2012
K100947 CALIBRA MEDICAL, INC. FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000 06/28/2010
K093065 CALIBRA MEDICAL, INC. FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000 01/20/2010
K163357 LifeScan Europe, a division of Cilag GmbH OneTouch Via On-Demand Insulin Delivery System 06/07/2017


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact