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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Pressure, Intracompartmental
510(k) Number K210525
Device Name MY01 Continuous Compartmental Pressure Monitor
Applicant
MY01, Inc.
400 De Maisonneuve Blvd. W., Suite 700
Montreal,  CA H3A 1LA
Applicant Contact Charles Allan
Correspondent
MY01, Inc.
400 De Maisonneuve Blvd. W., Suite 700
Montreal,  CA H3A 1LA
Correspondent Contact Anthony Sirgi
Classification Product Code
LXC  
Date Received02/23/2021
Decision Date 04/22/2021
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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