The following data is part of a premarket notification filed by Koven Technology, Inc. with the FDA for Valvulotome By Koven.
| Device ID | K080178 |
| 510k Number | K080178 |
| Device Name: | VALVULOTOME BY KOVEN |
| Classification | Valvulotome |
| Applicant | KOVEN TECHNOLOGY, INC. 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 -3404 |
| Contact | J. Harvey Knauss |
| Correspondent | J. Harvey Knauss KOVEN TECHNOLOGY, INC. 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 -3404 |
| Product Code | MGZ |
| CFR Regulation Number | 870.4885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-24 |
| Decision Date | 2008-07-28 |
| Summary: | summary |