The following data is part of a premarket notification filed by Intramed Laboratories, Inc. with the FDA for Valvulotome.
| Device ID | K925283 |
| 510k Number | K925283 |
| Device Name: | VALVULOTOME |
| Classification | Valvulotome |
| Applicant | INTRAMED LABORATORIES, INC. 11100 ROSELLE ST. San Diego, CA 92121 |
| Contact | Stephen A Sosnowski |
| Correspondent | Stephen A Sosnowski INTRAMED LABORATORIES, INC. 11100 ROSELLE ST. San Diego, CA 92121 |
| Product Code | MGZ |
| CFR Regulation Number | 870.4885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-20 |
| Decision Date | 1994-02-10 |