The following data is part of a premarket notification filed by Alphamedix, Inc. with the FDA for Glomark.
| Device ID | K830703 |
| 510k Number | K830703 |
| Device Name: | GLOMARK |
| Classification | Marker, Skin |
| Applicant | ALPHAMEDIX, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FZZ |
| CFR Regulation Number | 878.4660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-07 |
| Decision Date | 1983-04-28 |