The following data is part of a premarket notification filed by Abco Dealers, Inc. with the FDA for Skin Marking Pen.
| Device ID | K781770 |
| 510k Number | K781770 |
| Device Name: | SKIN MARKING PEN |
| Classification | Marker, Skin |
| Applicant | ABCO DEALERS, 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 | 1978-10-16 |
| Decision Date | 1978-11-15 |