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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Autotransfusion
510(k) Number K201305
Device Name Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain
Applicant
Atrium Medical Corporation
40 Continental Blvd.
Merrimack,  NH  03054
Applicant Contact Robin Mulvey
Correspondent
Atrium Medical Corporation
40 Continental Blvd.
Merrimack,  NH  03054
Correspondent Contact Robin Mulvey
Regulation Number868.5830
Classification Product Code
CAC  
Date Received05/15/2020
Decision Date 09/03/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Cardiovascular
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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