| 510(k) Number |
K851226 |
| Device Name |
I.V. START KIT |
| Applicant |
| Perry, Div. |
| 1875 Harsh Ave. SE |
| P.O. Box 550 |
|
Massillon,
OH
44648
|
|
| Applicant Contact |
JAMES R CHATTERTON |
| Correspondent |
| Perry, Div. |
| 1875 Harsh Ave. SE |
| P.O. Box 550 |
|
Massillon,
OH
44648
|
|
| Correspondent Contact |
JAMES R CHATTERTON |
| Date Received | 03/26/1985 |
| Decision Date | 05/01/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|