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

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