The following data is part of a premarket notification filed by Coltene, Inc. with the FDA for Coltene Coltex/coltoflax.
| Device ID | K811666 |
| 510k Number | K811666 |
| Device Name: | COLTENE COLTEX/COLTOFLAX |
| Classification | Material, Impression |
| Applicant | COLTENE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-06-15 |
| Decision Date | 1981-07-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J00644100 | K811666 | 000 |
| J00657150 | K811666 | 000 |
| J00657110 | K811666 | 000 |
| J00657010 | K811666 | 000 |
| J00643920 | K811666 | 000 |
| J00643650 | K811666 | 000 |
| J00642200 | K811666 | 000 |
| J00641900 | K811666 | 000 |
| J00641700 | K811666 | 000 |
| J00641650 | K811666 | 000 |
| J00641420 | K811666 | 000 |
| J00641200 | K811666 | 000 |
| J00640460 | K811666 | 000 |
| J00657160 | K811666 | 000 |
| J00657000 | K811666 | 000 |
| J00657100 | K811666 | 000 |
| J00644050 | K811666 | 000 |
| 07640181478682 | K811666 | 000 |
| 07640181478675 | K811666 | 000 |
| 07640181478668 | K811666 | 000 |
| 07640181478460 | K811666 | 000 |
| 07640181478446 | K811666 | 000 |
| 07640181478439 | K811666 | 000 |
| 07640181476978 | K811666 | 000 |
| 07640370883877 | K811666 | 000 |
| J00649990 | K811666 | 000 |
| J00649650 | K811666 | 000 |
| J00636510 | K811666 | 000 |
| J00640150 | K811666 | 000 |