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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dialyzer, high permeability with or without sealed dialysate system
510(k) Number K170790
Device Name SAM CRRT Unit, SAM Cassette CRRT
Spectral Medical Inc.
135 The West Mall, Unit 2
Toronto,  CA M9C 1C2
Applicant Contact Danijela Domljanovic
Amarex Clinical Research
20201 Century Boulevard, 4th Floor
Germantown,  MD  20874
Correspondent Contact Olga Pavlova
Regulation Number876.5860
Classification Product Code
Date Received03/16/2017
Decision Date 12/13/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No