The following data is part of a premarket notification filed by Calibra Medical, Inc. with the FDA for Finesse Personal Insulin Delivery Patch, Model Fg 2000.
| Device ID | K100947 |
| 510k Number | K100947 |
| Device Name: | FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000 |
| Classification | Pump, Infusion, Insulin Bolus |
| Applicant | CALIBRA MEDICAL, INC. 220 SAGINAW DRIVE Redwood City, CA 94063 |
| Contact | Richard J Meader |
| Correspondent | Richard J Meader CALIBRA MEDICAL, INC. 220 SAGINAW DRIVE Redwood City, CA 94063 |
| Product Code | OPP |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-06 |
| Decision Date | 2010-06-28 |
| Summary: | summary |