The following data is part of a premarket notification filed by A. Titan Instruments, Inc. with the FDA for Easy X-trac System.
| Device ID | K060691 |
| 510k Number | K060691 |
| Device Name: | EASY X-TRAC SYSTEM |
| Classification | Forceps, Tooth Extractor, Surgical |
| Applicant | A. TITAN INSTRUMENTS, INC. 97 MAIN ST. Hamburg, NY 14075 |
| Contact | Michael Tuber |
| Correspondent | Michael Tuber A. TITAN INSTRUMENTS, INC. 97 MAIN ST. Hamburg, NY 14075 |
| Product Code | EMG |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-15 |
| Decision Date | 2006-06-12 |
| Summary: | summary |