VITRIFREEZE MEDIUM; VITRITHAW MEDIUM

Media, Reproductive

FERTI PRO N.V.

The following data is part of a premarket notification filed by Ferti Pro N.v. with the FDA for Vitrifreeze Medium; Vitrithaw Medium.

Pre-market Notification Details

Device IDK070135
510k NumberK070135
Device Name:VITRIFREEZE MEDIUM; VITRITHAW MEDIUM
ClassificationMedia, Reproductive
Applicant FERTI PRO N.V. 3722 AVENUE SAUSALITO Irvine,  CA  92606
ContactGrace Holland
CorrespondentGrace Holland
FERTI PRO N.V. 3722 AVENUE SAUSALITO Irvine,  CA  92606
Product CodeMQL  
CFR Regulation Number884.6180 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-01-16
Decision Date2007-08-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05411967002139 K070135 000
05411967002122 K070135 000
05411967002115 K070135 000
05411967002108 K070135 000
05411967002054 K070135 000
05411967002047 K070135 000
05411967002030 K070135 000
05411967001439 K070135 000
05411967001415 K070135 000

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