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 |
D6620704514270 | K974772 | 000 |
D6620704115950 | K974772 | 000 |