The following data is part of a premarket notification filed by Myocure, Inc. with the FDA for Ophthalmic Knife W/removale Depth Guide.
| Device ID | K853598 |
| 510k Number | K853598 |
| Device Name: | OPHTHALMIC KNIFE W/REMOVALE DEPTH GUIDE |
| Classification | Knife, Ophthalmic |
| Applicant | MYOCURE, INC. 350 W. COLORADO BLVD. 500 P.O. BOX 7068 Pasadena, CA 91109 |
| Contact | Philip Anderson |
| Correspondent | Philip Anderson MYOCURE, INC. 350 W. COLORADO BLVD. 500 P.O. BOX 7068 Pasadena, CA 91109 |
| Product Code | HNN |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-27 |
| Decision Date | 1985-11-04 |