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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 K121409
Device Name ASAHI REXEED-SX/LX SERIES DIALYZER
Applicant
Asahi Kasei Medical Co., Ltd.
154 Main St., Suite #2
Charlestown,  NH  03603
Applicant Contact Patsy Trisler
Correspondent
Asahi Kasei Medical Co., Ltd.
154 Main St., Suite #2
Charlestown,  NH  03603
Correspondent Contact Patsy Trisler
Regulation Number876.5860
Classification Product Code
KDI  
Date Received05/11/2012
Decision Date 02/06/2013
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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