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 |