VENUS FLOW

Material, Tooth Shade, Resin

HERAEUS KULZER, INC.

The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Venus Flow.

Pre-market Notification Details

Device IDK033665
510k NumberK033665
Device Name:VENUS FLOW
ClassificationMaterial, Tooth Shade, Resin
Applicant HERAEUS KULZER, INC. 4315 SOUTH LAFAYETTE BLVD. South Bend,  IN  46614 -2517
ContactCheryl V Zimmerman
CorrespondentCheryl V Zimmerman
HERAEUS KULZER, INC. 4315 SOUTH LAFAYETTE BLVD. South Bend,  IN  46614 -2517
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-11-21
Decision Date2003-12-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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

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