The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Fuji Ii Lc (improved).
| Device ID | K961584 |
| 510k Number | K961584 |
| Device Name: | FUJI II LC (IMPROVED) |
| Classification | Cement, Dental |
| Applicant | GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803 |
| Contact | Terry L Jortiz |
| Correspondent | Terry L Jortiz GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-24 |
| Decision Date | 1996-05-24 |