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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 K170150
Device Name Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags
Applicant
S.A.L.F. Spa
Via Marconi 2
Cenate Sotto,  IT 24069
Applicant Contact Carmelo Gagliano
Correspondent
510k FDA Consulting / Denterprise International, Inc.
100 E Granada Blvd.
Suite 219
Ormond Beach,  FL  32176
Correspondent Contact Joyce St. Germain
Regulation Number876.5880
Classification Product Code
KDL  
Subsequent Product Code
MSB  
Date Received01/17/2017
Decision Date 10/20/2017
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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