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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name set, perfusion, kidney, disposable
510(k) Number K211842
Device Name Servator M SALF Solution
S.A.L.F. spa
Via Marconi 2
Cenate Sotto,  IT 32069
Applicant Contact Carmelo Gagliano
The 510k Consulting, LLC
1449 Springleaf Drive
Ormond Beach,  FL  32174
Correspondent Contact Joyce St. Germain
Regulation Number876.5880
Classification Product Code
Date Received06/15/2021
Decision Date 12/20/2021
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