| Device Classification Name |
Set, Administration, Intravascular
|
| 510(k) Number |
K963070 |
| Device Name |
VENIPUNCTURE KIT |
| Applicant |
| Miller Products and Services |
| 4515 Hwy. 47 N. |
|
Charlotte,
TN
37036
|
|
| Applicant Contact |
CINDY MILLER |
| Correspondent |
| Miller Products and Services |
| 4515 Hwy. 47 N. |
|
Charlotte,
TN
37036
|
|
| Correspondent Contact |
CINDY MILLER |
| Regulation Number | 880.5440 |
| Classification Product Code |
|
| Date Received | 08/07/1996 |
| Decision Date | 09/13/1996 |
| 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
|
|
|