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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, sensing, optical contour
510(k) Number K183485
Device Name CryoVizion System
Applicant
Cryos Technologies Inc.
385 rue Salaberry
Joliette,  CA J6E 4G4
Applicant Contact John A. Stimpson
Correspondent
LOK North America Inc.
2025 rue Michelin
Laval,  CA H7L 5B7
Correspondent Contact Louis-Paul Martin
Classification Product Code
LDK  
Date Received12/17/2018
Decision Date 08/28/2019
Decision Substantially Equivalent (SESE)
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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