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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 K223509
Device Name Compremium Compartment Compressibility Monitoring System (CPM#1)
Applicant
Compremium AG
Worbstrasse 46
Muri b. Bern,  CH 3074
Applicant Contact Vincent Baumann
Correspondent
Medidee Services LLC
300 Welsh Road, Building 1, Suite 100
Horsham,  PA  19044
Correspondent Contact Philippe Etter
Classification Product Code
LXC  
Date Received11/22/2022
Decision Date 04/14/2023
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Clinical Trials NCT05483946
Reviewed by Third Party No
Combination Product No
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