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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Suction, Patient Care
510(k) Number K212696
Device Name Aspira Pleural Drainage System
Applicant
Merit Medical Systems, Inc.
1600 W. Merit Pkwy.
South Jordan,  UT  84095
Applicant Contact Jennifer Webb
Correspondent
Merit Medical Systems, Inc.
1600 W. Merit Pkwy.
South Jordan,  UT  84095
Correspondent Contact Jennifer Webb
Regulation Number870.5050
Classification Product Code
DWM  
Date Received08/25/2021
Decision Date 03/03/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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