The following data is part of a premarket notification filed by Aspen Laboratories, Inc. with the FDA for Tmj Cannula Set.
| Device ID | K871648 |
| 510k Number | K871648 |
| Device Name: | TMJ CANNULA SET |
| Classification | Drill, Bone, Powered |
| Applicant | ASPEN LABORATORIES, INC. P.O. BOX 3936 Englewood, CO 80155 -3936 |
| Contact | Johnson |
| Correspondent | Johnson ASPEN LABORATORIES, INC. P.O. BOX 3936 Englewood, CO 80155 -3936 |
| Product Code | DZI |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-28 |
| Decision Date | 1987-06-08 |