The following data is part of a premarket notification filed by Coltene, Inc. with the FDA for Coltene Jet-mixer.
| Device ID | K863998 |
| 510k Number | K863998 |
| Device Name: | COLTENE JET-MIXER |
| Classification | Syringe, Restorative And Impression Material |
| Applicant | COLTENE, INC. C/O ROBERT BAUER & ASSOCIATES 111 N. WABASH Chicago, IL 60602 |
| Contact | Bauer, Ph.d. |
| Correspondent | Bauer, Ph.d. COLTENE, INC. C/O ROBERT BAUER & ASSOCIATES 111 N. WABASH Chicago, IL 60602 |
| Product Code | EID |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-14 |
| Decision Date | 1986-10-30 |