Pasteur Pipette 3mL, Pasteur Pipette 1mL

Labware, Assisted Reproduction

HertART Aps

The following data is part of a premarket notification filed by Hertart Aps with the FDA for Pasteur Pipette 3ml, Pasteur Pipette 1ml.

Pre-market Notification Details

Device IDK201213
510k NumberK201213
Device Name:Pasteur Pipette 3mL, Pasteur Pipette 1mL
ClassificationLabware, Assisted Reproduction
Applicant HertART Aps Gustaf Werners Gata 2 Vastra Frolunda,  SE Se-421 32
ContactPer Svensson
CorrespondentAnn-catherine Ericson
HertART Aps Gustaf Werners Gata 2 Vastra Frolunda,  SE Se-421 32
Product CodeMQK  
CFR Regulation Number884.6160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-05
Decision Date2020-12-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
17350025914623 K201213 000
17350025914616 K201213 000
17350025914623 K201213 000
17350025914616 K201213 000
17350025914623 K201213 000
17350025914616 K201213 000
17350025914623 K201213 000
17350025914616 K201213 000
17350025914623 K201213 000
17350025914616 K201213 000
17350025914623 K201213 000
17350025914616 K201213 000
17350025914623 K201213 000
17350025914623 K201213 000
17350025914616 K201213 000
17350025914616 K201213 000
17350025914623 K201213 000
17350025914616 K201213 000
17350025914623 K201213 000
17350025914616 K201213 000
17350025914623 K201213 000
17350025914616 K201213 000
17350025914623 K201213 000
17350025914616 K201213 000
17350025914623 K201213 000
17350025914616 K201213 000
17350025914623 K201213 000
17350025914616 K201213 000

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.