The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Delta-lite Casting Resin.
| Device ID | K854341 |
| 510k Number | K854341 |
| Device Name: | DELTA-LITE CASTING RESIN |
| Classification | Component, Cast |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Marsha J Stone |
| Correspondent | Marsha J Stone JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | LGF |
| CFR Regulation Number | 888.5940 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-28 |
| Decision Date | 1985-11-22 |