The following data is part of a premarket notification filed by Medisense, Inc. with the FDA for Precision G Blood Glucose Testing System.
| Device ID | K963676 |
| 510k Number | K963676 |
| Device Name: | PRECISION G BLOOD GLUCOSE TESTING SYSTEM |
| Classification | Glucose Oxidase, Glucose |
| Applicant | MEDISENSE, INC. 4A CROSBY DR. Bedford, MA 01730 |
| Contact | Michael Halpin |
| Correspondent | Michael Halpin MEDISENSE, INC. 4A CROSBY DR. Bedford, MA 01730 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-13 |
| Decision Date | 1997-02-20 |
| Summary: | summary |