VALVULOTOME BY KOVEN


Device Classification Name

valvulotome

510(k) Number K080178
Device Name VALVULOTOME BY KOVEN
Applicant
KOVEN TECHNOLOGY, INC.
11874 south evelyn circle
houston, 
TX 
77071 -3404

Applicant Contact j. harvey knauss
Correspondent
KOVEN TECHNOLOGY, INC.
11874 south evelyn circle
houston, 
TX 
77071 -3404

Correspodent Contact j. harvey knauss
Regulation Number 870.4885
Classification Product Code
MGZ  
Date Received 01/24/2008
Decision Date 07/28/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No