Media, Reproductive

Vitromed Langenfeld

The following data is part of a premarket notification filed by Vitromed Langenfeld with the FDA for V-hepes Plus.

Pre-market Notification Details

Device IDK213293
510k NumberK213293
Device Name:V-HEPES PLUS
ClassificationMedia, Reproductive
Applicant Vitromed Langenfeld Raoffeosemstr 15a Langenfeld,  DE 40764
ContactGreg Holland
CorrespondentGreg Holland
Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine,  CA  92606
Product CodeMQL  
CFR Regulation Number884.6180 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-10-01
Decision Date2022-09-14

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