The following data is part of a premarket notification filed by Myocure, Inc. with the FDA for Ophthalmic Surgical Ocular Markers.
| Device ID | K863663 |
| 510k Number | K863663 |
| Device Name: | OPHTHALMIC SURGICAL OCULAR MARKERS |
| Classification | Marker, Ocular |
| Applicant | MYOCURE, INC. 1736 FLOWER ST. Glendale, CA 91201 |
| Contact | Alex C Jensen |
| Correspondent | Alex C Jensen MYOCURE, INC. 1736 FLOWER ST. Glendale, CA 91201 |
| Product Code | HMR |
| CFR Regulation Number | 886.4570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-18 |
| Decision Date | 1986-10-20 |