The following data is part of a premarket notification filed by Myocure, Inc. with the FDA for Surgical Skin Marker.
| Device ID | K864371 |
| 510k Number | K864371 |
| Device Name: | SURGICAL SKIN MARKER |
| Classification | Marker, Skin |
| Applicant | MYOCURE, INC. 1736 FLOWER ST. Glendale, CA 91201 |
| Contact | C.jensen, M.d. |
| Correspondent | C.jensen, M.d. MYOCURE, INC. 1736 FLOWER ST. Glendale, CA 91201 |
| Product Code | FZZ |
| CFR Regulation Number | 878.4660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-05 |
| Decision Date | 1986-11-17 |