The following data is part of a premarket notification filed by Coltene, Inc. with the FDA for Coltene Precise.
| Device ID | K850036 |
| 510k Number | K850036 |
| Device Name: | COLTENE PRECISE |
| Classification | Material, Impression |
| Applicant | COLTENE, INC. C/O ROBERT BAUER & ASSOCIATES 111 N. WABASH Chicago, IL 60602 |
| Contact | Robert W Bauer |
| Correspondent | Robert W Bauer COLTENE, INC. C/O ROBERT BAUER & ASSOCIATES 111 N. WABASH Chicago, IL 60602 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-07 |
| Decision Date | 1985-02-08 |