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510(k) K241341

cryo-GO Vitrification Device by Fujifilm Irvine Scientific — Product Code MQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2024
Date Received
May 13, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Labware, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6160
Review Panel
OB
Submission Type

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