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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 K202635
Device Name MY01 Continuous Compartmental Pressure Monitor
Applicant
MY01, Inc.
400 De Maisonneuve Blvd. W.
Suite 700
Montréal,  CA H3A 1L4
Applicant Contact Charles Allan
Correspondent
MY01, Inc.
400 De Maisonneuve Blvd. W.
Suite 700
Montréal,  CA H3A 1L4
Correspondent Contact Anthony Sirgi
Classification Product Code
LXC  
Date Received09/11/2020
Decision Date 12/10/2020
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
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