The following data is part of a premarket notification filed by Glytec, Llc (formally Known As Glucotec, Inc.) with the FDA for G+ System.
| Device ID | K101344 |
| 510k Number | K101344 |
| Device Name: | G+ SYSTEM |
| Classification | Calculator, Drug Dose |
| Applicant | GLYTEC, LLC (FORMALLY KNOWN AS GLUCOTEC, INC.) 2607 WOODRUFF RD Simpsonville, SC 29681 |
| Contact | William Matthews |
| Correspondent | William Matthews GLYTEC, LLC (FORMALLY KNOWN AS GLUCOTEC, INC.) 2607 WOODRUFF RD Simpsonville, SC 29681 |
| Product Code | NDC |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-13 |
| Decision Date | 2010-06-28 |
| Summary: | summary |