Transem And EchoGen Embryo Transfer Catheters

Catheter, Assisted Reproduction

ORIGIO A/S

The following data is part of a premarket notification filed by Origio A/s with the FDA for Transem And Echogen Embryo Transfer Catheters.

Pre-market Notification Details

Device IDK161547
510k NumberK161547
Device Name:Transem And EchoGen Embryo Transfer Catheters
ClassificationCatheter, Assisted Reproduction
Applicant ORIGIO A/S KNARDRUPVEJ 2 Maaloev,  DK 2760
ContactTove Kjaer
CorrespondentTove Kjaer
ORIGIO A/S KNARDRUPVEJ 2 Maaloev,  DK 2760
Product CodeMQF  
CFR Regulation Number884.6110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-06-03
Decision Date2017-03-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20888937972799 K161547 000
20888937972379 K161547 000
20888937972362 K161547 000
20888937972355 K161547 000
20888937972348 K161547 000

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