The following data is part of a premarket notification filed by Vee Gee Scientific, Inc. with the FDA for Model 3461 Clinical Refractometer.
| Device ID | K941905 |
| 510k Number | K941905 |
| Device Name: | MODEL 3461 CLINICAL REFRACTOMETER |
| Classification | Refractometer For Clinical Use |
| Applicant | VEE GEE SCIENTIFIC, INC. 13600 N.E. 126TH PL., SUITE A Kirkland, WA 98034 |
| Contact | Steve Lytle |
| Correspondent | Steve Lytle VEE GEE SCIENTIFIC, INC. 13600 N.E. 126TH PL., SUITE A Kirkland, WA 98034 |
| Product Code | JRE |
| CFR Regulation Number | 862.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-19 |
| Decision Date | 1994-12-13 |