ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800


Device Classification Name

ring, annuloplasty

510(k) Number K023185
Device Name ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800
Original Applicant
SULZER CARBOMEDICS, INC.
1300 east anderson ln.
austin, 
TX 
78752

Original Contact teffany hankinson
Regulation Number 870.3800
Classification Product Code
KRH  
Date Received 09/24/2002
Decision Date 12/17/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No