| Device Classification Name |
Refractometer For Clinical Use
|
| 510(k) Number |
K941906 |
| Device Name |
MODEL 2730 CLINICAL REFRACTOMETER |
| Applicant |
| Vee Gee Scientific, Inc. |
| 13600 NE 126th Pl., Suite A |
|
Kirkland,
WA
98034
|
|
| Applicant Contact |
STEVE LYTLE |
| Correspondent |
| Vee Gee Scientific, Inc. |
| 13600 NE 126th Pl., Suite A |
|
Kirkland,
WA
98034
|
|
| Correspondent Contact |
STEVE LYTLE |
| Regulation Number | 862.2800 |
| Classification Product Code |
|
| Date Received | 04/19/1994 |
| Decision Date | 01/17/1995 |
| 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
|
|
|