The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Venus Flow.
Device ID | K033665 |
510k Number | K033665 |
Device Name: | VENUS FLOW |
Classification | Material, Tooth Shade, Resin |
Applicant | HERAEUS KULZER, INC. 4315 SOUTH LAFAYETTE BLVD. South Bend, IN 46614 -2517 |
Contact | Cheryl V Zimmerman |
Correspondent | Cheryl V Zimmerman HERAEUS KULZER, INC. 4315 SOUTH LAFAYETTE BLVD. South Bend, IN 46614 -2517 |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-11-21 |
Decision Date | 2003-12-30 |