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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System And Accessories, Isolated Heart, Transport And Preservation
510(k) Number K222535
Device Name OCS Lung Donor Flush Set
Applicant
TransMedics, Inc.
200 Minuteman Rd.
Suite 302
Andover,  MA  01810
Applicant Contact Miriam Provost
Correspondent
TransMedics, Inc.
200 Minuteman Rd.
Suite 302
Andover,  MA  01810
Correspondent Contact Miriam Provost
Regulation Number876.5880
Classification Product Code
MSB  
Date Received08/22/2022
Decision Date 11/18/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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