The following data is part of a premarket notification filed by Coe Laboratories, Inc. with the FDA for Absolute Vinyl Polysiloxane Impress.
| Device ID | K842877 |
| 510k Number | K842877 |
| Device Name: | ABSOLUTE VINYL POLYSILOXANE IMPRESS |
| Classification | Material, Impression |
| Applicant | COE LABORATORIES, INC. 3737 W. 127TH ST. Alsip, IL 60658 |
| Contact | Brahma D Sharma |
| Correspondent | Brahma D Sharma 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 | 1984-07-23 |
| Decision Date | 1985-03-11 |