Follicle Aspiration Set, Reduced Single Lumen

Needle, Assisted Reproduction

Vitrolife Sweden AB

The following data is part of a premarket notification filed by Vitrolife Sweden Ab with the FDA for Follicle Aspiration Set, Reduced Single Lumen.

Pre-market Notification Details

Device IDK172050
510k NumberK172050
Device Name:Follicle Aspiration Set, Reduced Single Lumen
ClassificationNeedle, Assisted Reproduction
Applicant Vitrolife Sweden AB Gustaf Werners Gata 2 Vastra Frolunda,  SE Se-42132
ContactAnja Bengtzelius
CorrespondentGreg Holland
Regulatory Specialist, Inc. 3722 Ave. Sausalito Irvine,  CA  92606
Product CodeMQE  
CFR Regulation Number884.6100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-06
Decision Date2017-11-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
17350025915460 K172050 000
17350025915453 K172050 000
17350025915446 K172050 000
17350025915439 K172050 000
17350025915682 K172050 000
07350025915678 K172050 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.