The following data is part of a premarket notification filed by Myocure, Inc. with the FDA for Myocur Blade Pac.
| Device ID | K822392 |
| 510k Number | K822392 |
| Device Name: | MYOCUR BLADE PAC |
| Classification | Suture, Nonabsorable, Ophthalmic |
| Applicant | MYOCURE, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HMN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-09 |
| Decision Date | 1982-08-25 |