| Device Classification Name |
Tubes, Vials, Systems, Serum Separators, Blood Collection
|
| 510(k) Number |
K902709 |
| Device Name |
SECUTAINER |
| Applicant |
| Preserve |
| 32255 Northwestern Hwy. |
| Suite 254 |
|
Farmington Hills,
MI
48018
|
|
| Applicant Contact |
MAURICE REISMAN |
| Correspondent |
| Preserve |
| 32255 Northwestern Hwy. |
| Suite 254 |
|
Farmington Hills,
MI
48018
|
|
| Correspondent Contact |
MAURICE REISMAN |
| Regulation Number | 862.1675 |
| Classification Product Code |
|
| Date Received | 06/20/1990 |
| Decision Date | 07/27/1990 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Clinical Chemistry
|
| 510k Review Panel |
Clinical Chemistry
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|