The following data is part of a premarket notification filed by E.m. Adams with the FDA for Disposable Skin Marking Pen.
| Device ID | K843116 |
| 510k Number | K843116 |
| Device Name: | DISPOSABLE SKIN MARKING PEN |
| Classification | Marker, Skin |
| Applicant | E.M. ADAMS 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 | 1984-08-08 |
| Decision Date | 1984-08-17 |