CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH

Labware, Assisted Reproduction

HERTART

The following data is part of a premarket notification filed by Hertart with the FDA for Culture Dish 40 Mm, Culture Dish 60 Mm, Micro Droplet Culture Dish, 5 Well Culture Dish, Centre Well Dish, Icsi Dish.

Pre-market Notification Details

Device IDK123641
510k NumberK123641
Device Name:CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH
ClassificationLabware, Assisted Reproduction
Applicant HERTART KORSKILDELUND 6 Greve,  DK 2670
ContactHenrik Dorge
CorrespondentHenrik Dorge
HERTART KORSKILDELUND 6 Greve,  DK 2670
Product CodeMQK  
CFR Regulation Number884.6160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-11-26
Decision Date2013-07-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
27350025914538 K123641 000
27350025914521 K123641 000
27350025914514 K123641 000
27350025914507 K123641 000
27350025914491 K123641 000
27350025914484 K123641 000

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