The following data is part of a premarket notification filed by Coltene, Inc. with the FDA for Coltene Rapid.
| Device ID | K870047 |
| 510k Number | K870047 |
| Device Name: | COLTENE RAPID |
| Classification | Material, Impression |
| Applicant | COLTENE, INC. C/O ROBERT BAUER & ASSOCIATES 111 N. WABASH Chicago, IL 60602 |
| Contact | Bauer, Phd |
| Correspondent | Bauer, Phd 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 | 1987-01-06 |
| Decision Date | 1987-01-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J00645900 | K870047 | 000 |
| J00645500 | K870047 | 000 |
| J00645470 | K870047 | 000 |
| J00645410 | K870047 | 000 |
| J00645400 | K870047 | 000 |
| J00645300 | K870047 | 000 |
| J00645150 | K870047 | 000 |