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 |