OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE

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 Oil For Tissue Culture, Gradient System And Spermfreeze.

Pre-market Notification Details

Device IDK053494
510k NumberK053494
Device Name:OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE
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 ProductYes
Date Received2005-12-15
Decision Date2006-03-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05411967000067 K053494 000
05411967001385 K053494 000
05411967003457 K053494 000
05411967005703 K053494 000
54119670001734 K053494 000
54119670001802 K053494 000
54119670009822 K053494 000
54119670009990 K053494 000
54119670010194 K053494 000
54119670010262 K053494 000
54119670010330 K053494 000
54119670010576 K053494 000
05411967002016 K053494 000
05411967002009 K053494 000
05411967000142 K053494 000
05411967000074 K053494 000
05411967000081 K053494 000
05411967000098 K053494 000
05411967000852 K053494 000
05411967000869 K053494 000
05411967000876 K053494 000
05411967000883 K053494 000
05411967000890 K053494 000
05411967001316 K053494 000
05411967001323 K053494 000
05411967000159 K053494 000
54119670010644 K053494 000
54119670010712 K053494 000
00858604006191 K053494 000
00858604006207 K053494 000
00858604006214 K053494 000
00859268006152 K053494 000
00859268006169 K053494 000
00859268006176 K053494 000
00859268006183 K053494 000
00859268006190 K053494 000
00859268006206 K053494 000
00859268006213 K053494 000
00859268006220 K053494 000
00858604006184 K053494 000
00858604006177 K053494 000
00858604006146 K053494 000
54119670010880 K053494 000
54119670011184 K053494 000
54119670011566 K053494 000
54119670011634 K053494 000
54119670011870 K053494 000
54119670012174 K053494 000
54119670012242 K053494 000
54119670012310 K053494 000
54119670012488 K053494 000
54119670012792 K053494 000
54119670012860 K053494 000
00859268006237 K053494 000

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