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510(k) K221086

Device
CryoRobot Select System
Applicant
TMRW Life Sciences, Inc.
510(k) number
K221086
Product code
QUJ  
Decision
Substantially Equivalent (SESE)
Decision date
2022-11-04
Date received
2022-04-13
Regulation
884.6120
Classification name
Automated Cryopreservation Storage System
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Christina Miracle
Address
250 Hudson St. Floor 6 New York NY US 10013 10013

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

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FDA Review#

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