The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Acl Drill Guide System.
| Device ID | K892655 |
| 510k Number | K892655 |
| Device Name: | ACL DRILL GUIDE SYSTEM |
| Classification | Guide, Drill, Ligament |
| Applicant | BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana, CA 92711 |
| Contact | Radlick, Phd |
| Correspondent | Radlick, Phd BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana, CA 92711 |
| Product Code | LXI |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-13 |
| Decision Date | 1989-09-28 |