The following data is part of a premarket notification filed by Symcare Personalized Health Solutions, Inc with the FDA for Symcare Diabetes Management Program.
| Device ID | K083263 |
| 510k Number | K083263 |
| Device Name: | SYMCARE DIABETES MANAGEMENT PROGRAM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | SYMCARE PERSONALIZED HEALTH SOLUTIONS, INC 200 LAWRENCE DRIVE West Chester, PA 19380 |
| Contact | Rae Ann Delay |
| Correspondent | Rae Ann Delay SYMCARE PERSONALIZED HEALTH SOLUTIONS, INC 200 LAWRENCE DRIVE West Chester, PA 19380 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-05 |
| Decision Date | 2009-03-13 |
| Summary: | summary |