Device Classification Name |
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
More FDA Info for this Device |
510(K) Number |
K101866 |
Device Name |
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
Applicant |
CRYOLIFE, INC.
1655 ROBERTS BLVD., N.W.
KENNESAW, GA 30144 US
Other 510(k) Applications for this Company
|
Contact |
JOHN D FERROS
Other 510(k) Applications for this Contact |
Regulation Number |
870.3470
More FDA Info for this Regulation Number |
Classification Product Code |
DXZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
07/02/2010 |
Decision Date |
07/23/2010 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
CV - Cardiovascular |
Review Advisory Committee |
CV - Cardiovascular |
Statement / Summary / Purged Status |
Summary |
Type |
Special |
Reviewed By Third Party |
N |
Expedited Review |
|