ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800


Device Classification Name

ring, annuloplasty

510(k) Number K992056
Device Name ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800
Applicant
SULZER CARBOMEDICS, INC.
1300 east anderson ln.
austin, 
TX 
78752

Applicant Contact robert m wolfarth
Correspondent
SULZER CARBOMEDICS, INC.
1300 east anderson ln.
austin, 
TX 
78752

Correspodent Contact robert m wolfarth
Regulation Number 870.3800
Classification Product Code
KRH  
Date Received 06/18/1999
Decision Date 10/12/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No