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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Perfusion, Kidney
510(k) Number K240650
Device Name LungProtect
Applicant
Traferox Technologies Inc.
3505 Laird Rd. Unit 16
Mississauga,  CA L5L5Y7
Applicant Contact Nicole Baker
Correspondent
Traferox Technologies Inc.
3505 Laird Rd. Unit 16
Mississauga,  CA L5L5Y7
Correspondent Contact Nicole Baker
Regulation Number876.5880
Classification Product Code
KDN  
Date Received03/07/2024
Decision Date 11/26/2024
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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