| Device Classification Name |
Stopcock, I.V. Set
|
| 510(k) Number |
K884435 |
| Device Name |
RESUBMITTED 1,3 & 4 WAY STOPCOCKS, VARIOUS PARTS |
| Applicant |
| Clinical Connections, Inc. |
| P.O. Box 238 |
| 9287 Smucker Rd. |
|
Orrville,
OH
44667
|
|
| Applicant Contact |
FRED COOK |
| Correspondent |
| Clinical Connections, Inc. |
| P.O. Box 238 |
| 9287 Smucker Rd. |
|
Orrville,
OH
44667
|
|
| Correspondent Contact |
FRED COOK |
| Regulation Number | 880.5440 |
| Classification Product Code |
|
| Date Received | 10/13/1988 |
| Decision Date | 11/08/1988 |
| 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
|
|
|