The following data is part of a premarket notification filed by Coe Laboratories, Inc. with the FDA for Accuflex/accumix Vinyl Poly Impression Materials.
| Device ID | K903292 |
| 510k Number | K903292 |
| Device Name: | ACCUFLEX/ACCUMIX VINYL POLY IMPRESSION MATERIALS |
| Classification | Material, Impression |
| Applicant | COE LABORATORIES, INC. 3737 W. 127TH ST. Alsip, IL 60658 |
| Contact | Richard S Demke |
| Correspondent | Richard S 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 | 1990-07-24 |
| Decision Date | 1990-10-19 |