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510(k) K183486

RapidVit™ Oocyte, RapidWarm™ Oocyte by Vitrolife Sweden AB — Product Code MQL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2019
Date Received
December 17, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Reproductive
Device Class
Class II
Regulation Number
884.6180
Review Panel
OB
Submission Type

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