The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Ufi Gel C.
| Device ID | K974772 |
| 510k Number | K974772 |
| Device Name: | UFI GEL C |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | VOCO GMBH 7527 WESTMORELAND AVE. St. Louis, MO 63105 |
| Contact | Evan Dick |
| Correspondent | Evan Dick VOCO GMBH 7527 WESTMORELAND AVE. St. Louis, MO 63105 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-22 |
| Decision Date | 1998-02-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D6620704514432 | K974772 | 000 |
| D6620704514352 | K974772 | 000 |