The following data is part of a premarket notification filed by Coe Laboratories, Inc. with the FDA for Coe-lite Polymerization Unit.
| Device ID | K844325 |
| 510k Number | K844325 |
| Device Name: | COE-LITE POLYMERIZATION UNIT |
| Classification | Activator, Ultraviolet, For Polymerization |
| 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 | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-07 |
| Decision Date | 1984-12-11 |