HUMAN HEART VALVE, CRYOVALVE SG

Device Classification Name

heart valve, more than minimally manipulated allograft

510(k) Number K033484
Device Name HUMAN HEART VALVE, CRYOVALVE SG
Applicant
CRYOLIFE, INC.
1655 roberts blvd., n.w.
kennesaw, 
GA 
30144

Applicant Contact david m fronk
Correspondent
CRYOLIFE, INC.
1655 roberts blvd., n.w.
kennesaw, 
GA 
30144

Correspodent Contact david m fronk
Classification Product Code
OHA  
Date Received 11/04/2003
Decision Date 02/07/2008
Decision

substantially equivalent

(SESE)

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls