| Device Classification Name |
Pump, Infusion
|
| 510(k) Number |
K031600 |
| Device Name |
CONDUCTION CATHETER |
| Applicant |
| Micor, Inc. |
| 2855 Oxford Blvd. |
|
Allison Park,
PA
15101
|
|
| Applicant Contact |
SUSAN FORGRAVE |
| Correspondent |
| Micor, Inc. |
| 2855 Oxford Blvd. |
|
Allison Park,
PA
15101
|
|
| Correspondent Contact |
SUSAN FORGRAVE |
| Regulation Number | 880.5725 |
| Classification Product Code |
|
| Date Received | 05/21/2003 |
| Decision Date | 08/13/2003 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|