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510(k) K183485

CryoVizion System by Cryos Technologies, Inc. — Product Code LDK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2019
Date Received
December 17, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Sensing, Optical Contour
Device Class
Class U
Regulation Number
Review Panel
PM
Submission Type

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