The following data is part of a premarket notification filed by Dermacare Products, Inc. with the FDA for Dermamarker.
| Device ID | K863280 |
| 510k Number | K863280 |
| Device Name: | DERMAMARKER |
| Classification | Marker, Skin |
| Applicant | DERMACARE PRODUCTS, INC. 7651 NATIONAL TURNPIKE Louisville, KT 40214 |
| Contact | Ken Potts |
| Correspondent | Ken Potts DERMACARE PRODUCTS, INC. 7651 NATIONAL TURNPIKE Louisville, KT 40214 |
| Product Code | FZZ |
| CFR Regulation Number | 878.4660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-25 |
| Decision Date | 1986-09-09 |