The following data is part of a premarket notification filed by Kab Gloves Unltd. with the FDA for Cu-75 Visible Light-curing Unit.
| Device ID | K900135 |
| 510k Number | K900135 |
| Device Name: | CU-75 VISIBLE LIGHT-CURING UNIT |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | KAB GLOVES UNLTD. P.O. BOX 725277 Berkley, MI 48072 |
| Contact | Kirit A Bhatt |
| Correspondent | Kirit A Bhatt KAB GLOVES UNLTD. P.O. BOX 725277 Berkley, MI 48072 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-10 |
| Decision Date | 1990-05-07 |