The following data is part of a premarket notification filed by Glytec, Llc with the FDA for G+ System.
| Device ID | K113853 |
| 510k Number | K113853 |
| Device Name: | G+ SYSTEM |
| Classification | Calculator, Drug Dose |
| Applicant | GLYTEC, LLC 665 N. ACADEMY ST. Greenville, SC 29601 |
| Contact | William Matthews |
| Correspondent | William Matthews GLYTEC, LLC 665 N. ACADEMY ST. Greenville, SC 29601 |
| Product Code | NDC |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-29 |
| Decision Date | 2012-05-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860057000305 | K113853 | 000 |