Device Classification Name |
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
More FDA Info for this Device |
510(K) Number |
K001785 |
Device Name |
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
Applicant |
COOK BIOTECH, INC.
3055 KENT AVE.
WEST LAFAYETTE, IN 47906-1076 US
Other 510(k) Applications for this Company
|
Contact |
NEAL E FEARNOT
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 |
06/13/2000 |
Decision Date |
12/27/2000 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
CV - Cardiovascular |
Review Advisory Committee |
CV - Cardiovascular |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|