The following data is part of a premarket notification filed by Coltene, Inc. with the FDA for Coltene Pressure Spot Indicator.
| Device ID | K811667 |
| 510k Number | K811667 |
| Device Name: | COLTENE PRESSURE SPOT INDICATOR |
| 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 |