Device Classification Name |
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
More FDA Info for this Device |
510(K) Number |
K003070 |
Device Name |
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
Applicant |
ETHICON, INC.
ROUTE 22 WEST
P.O. BOX 151
SOMERVILLE, NJ 08876-0151 US
Other 510(k) Applications for this Company
|
Contact |
GREGORY R JONES
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 |
10/02/2000 |
Decision Date |
11/07/2000 |
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 |
|