The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Exactech(tm).
| Device ID | K863468 |
| 510k Number | K863468 |
| Device Name: | EXACTECH(TM) |
| Classification | Glucose Oxidase, Glucose |
| Applicant | TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
| Contact | Carabillo, Jr |
| Correspondent | Carabillo, Jr TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-08 |
| Decision Date | 1986-12-08 |