| Device Classification Name |
Needle, Hypodermic, Single Lumen
|
| 510(k) Number |
K031058 |
| Device Name |
CORD STICK MULTIPLE DRAW SYSTEM |
| Applicant |
| Cord Stick Corp. |
| 1400 Florida Ave., Suite 205 |
|
Modesto,
CA
95350
|
|
| Applicant Contact |
MICHAEL MOEN |
| Correspondent |
| Cord Stick Corp. |
| 1400 Florida Ave., Suite 205 |
|
Modesto,
CA
95350
|
|
| Correspondent Contact |
MICHAEL MOEN |
| Regulation Number | 880.5570 |
| Classification Product Code |
|
| Subsequent Product Code |
|
| Date Received | 04/03/2003 |
| Decision Date | 06/13/2003 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Statement |
Statement
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|