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 |