The following data is part of a premarket notification filed by Medisense, Inc. with the FDA for Exactech Rsg Blood Glucose Testing System.
| Device ID | K961337 |
| 510k Number | K961337 |
| Device Name: | EXACTECH RSG BLOOD GLUCOSE TESTING SYSTEM |
| Classification | Glucose Oxidase, Glucose |
| Applicant | MEDISENSE, INC. 266 SECOND AVE. Waltham, MA 02154 |
| Contact | David Wong |
| Correspondent | David Wong MEDISENSE, INC. 266 SECOND AVE. Waltham, MA 02154 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-08 |
| Decision Date | 1996-06-21 |
| Summary: | summary |