The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Admira Flow.
Device ID | K011756 |
510k Number | K011756 |
Device Name: | ADMIRA FLOW |
Classification | Material, Tooth Shade, Resin |
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 | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-06-06 |
Decision Date | 2001-07-18 |
Summary: | summary |