The following data is part of a premarket notification filed by Coe Laboratories, Inc. with the FDA for First Impression With Chlorhexidine.
| Device ID | K894281 |
| 510k Number | K894281 |
| Device Name: | FIRST IMPRESSION WITH CHLORHEXIDINE |
| Classification | Material, Impression |
| Applicant | COE LABORATORIES, INC. 3737 W. 127TH ST. Alsip, IL 60658 |
| Contact | Richard Demke |
| Correspondent | Richard Demke COE LABORATORIES, INC. 3737 W. 127TH ST. Alsip, IL 60658 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-23 |
| Decision Date | 1989-09-26 |