The following data is part of a premarket notification filed by Innovators, Inc. with the FDA for Opti-lite.
| Device ID | K844351 |
| 510k Number | K844351 |
| Device Name: | OPTI-LITE |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | INNOVATORS, INC. 2721 D INDUSTRIAL DR. Jefferson City, MO 65109 -0771 |
| Contact | Don C Gentry |
| Correspondent | Don C Gentry INNOVATORS, INC. 2721 D INDUSTRIAL DR. Jefferson City, MO 65109 -0771 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-09 |
| Decision Date | 1984-12-21 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() OPTI-LITE 85483376 4189730 Dead/Cancelled |
BPREX HEALTHCARE PACKAGING INC. 2011-11-30 |
![]() OPTI-LITE 77740906 3769200 Live/Registered |
JIKOH Manufacturing, Inc. 2009-05-20 |
![]() OPTI-LITE 76233561 not registered Dead/Abandoned |
TRANSMISSION TECHNOLOGIES CORPORATION 2001-03-30 |
![]() OPTI-LITE 74437803 1892648 Dead/Cancelled |
Sharp International Corp. 1993-09-20 |
![]() OPTI-LITE 73319939 1212276 Dead/Cancelled |
Nimslo Technology Limited 1981-07-20 |