The following data is part of a premarket notification filed by Myocure, Inc. with the FDA for Cystotomes/knifes.
| Device ID | K880345 |
| 510k Number | K880345 |
| Device Name: | CYSTOTOMES/KNIFES |
| Classification | Cystotome |
| Applicant | MYOCURE, INC. 1736 FLOWER ST. Glendale, CA 91201 |
| Contact | Jensen, Md |
| Correspondent | Jensen, Md MYOCURE, INC. 1736 FLOWER ST. Glendale, CA 91201 |
| Product Code | HNY |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-26 |
| Decision Date | 1988-05-03 |