Device Classification Name |
Catheter, Conduction, Anesthetic
|
510(k) Number |
K032390 |
Device Name |
MODIFICATION TO EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM |
Applicant |
EBI, L.P. |
399 JEFFERSON ROAD |
PARSIPPANY,
NJ
07054
|
|
Applicant Contact |
BARRY SANDS |
Correspondent |
EBI, L.P. |
399 JEFFERSON ROAD |
PARSIPPANY,
NJ
07054
|
|
Correspondent Contact |
BARRY SANDS |
Regulation Number | 868.5120
|
Classification Product Code |
|
Date Received | 08/04/2003 |
Decision Date | 08/29/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|