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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J014660145730 | K033665 | 000 |
| J014660145630 | K033665 | 000 |
| J014660145640 | K033665 | 000 |
| J014660145650 | K033665 | 000 |
| J014660145660 | K033665 | 000 |
| J014660145670 | K033665 | 000 |
| J014660145680 | K033665 | 000 |
| J014660145690 | K033665 | 000 |
| J014660145700 | K033665 | 000 |
| J014660145710 | K033665 | 000 |
| J014660145740 | K033665 | 000 |
| J014660145750 | K033665 | 000 |
| J014660145610 | K033665 | 000 |
| J014660145720 | K033665 | 000 |
| J014660145620 | K033665 | 000 |