The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Fuji Ii Lc Capsule.
| Device ID | K993973 |
| 510k Number | K993973 |
| Device Name: | FUJI II LC CAPSULE |
| Classification | Material, Tooth Shade, Resin |
| Applicant | GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803 |
| Contact | Terry L Joritz |
| Correspondent | Terry L Joritz GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-23 |
| Decision Date | 2000-01-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00386040008825 | K993973 | 000 |
| 00386040008726 | K993973 | 000 |
| 00386040008733 | K993973 | 000 |
| 00386040008740 | K993973 | 000 |
| 00386040008757 | K993973 | 000 |
| 00386040008764 | K993973 | 000 |
| 00386040008771 | K993973 | 000 |
| 00386040008788 | K993973 | 000 |
| 00386040008795 | K993973 | 000 |
| 00386040008801 | K993973 | 000 |
| 00386040008818 | K993973 | 000 |
| 00386040008719 | K993973 | 000 |