The following data is part of a premarket notification filed by Myocure, Inc. with the FDA for Ophthalmic Surgical Speculum.
| Device ID | K863664 |
| 510k Number | K863664 |
| Device Name: | OPHTHALMIC SURGICAL SPECULUM |
| Classification | Specula, Ophthalmic |
| Applicant | MYOCURE, INC. 1736 FLOWER ST. Glendale, CA 91201 |
| Contact | Alexa C Jensen |
| Correspondent | Alexa C Jensen MYOCURE, INC. 1736 FLOWER ST. Glendale, CA 91201 |
| Product Code | HNC |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-18 |
| Decision Date | 1986-09-25 |