The following data is part of a premarket notification filed by Xomed-treace, Inc. with the FDA for Blackstar(tm) Star System.
| Device ID | K945659 |
| 510k Number | K945659 |
| Device Name: | BLACKSTAR(TM) STAR SYSTEM |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | XOMED-TREACE, INC. 6743 SOUTHPOINT DRIVE NORTH Jacksonville, FL 32216 -0980 |
| Product Code | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-17 |
| Decision Date | 1995-01-09 |