| Device Classification Name |
Set, Administration, Intravascular
|
| 510(k) Number |
K913337 |
| Device Name |
INJECTION CAP |
| Applicant |
| Cp Medical |
| P.O. Box 5668 |
|
Huntington Beach,
CA
92615
|
|
| Applicant Contact |
CARL GRODACH |
| Correspondent |
| Cp Medical |
| P.O. Box 5668 |
|
Huntington Beach,
CA
92615
|
|
| Correspondent Contact |
CARL GRODACH |
| Regulation Number | 880.5440 |
| Classification Product Code |
|
| Date Received | 07/26/1991 |
| Decision Date | 02/11/1992 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|