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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 K082515
Device Name ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX
Applicant
Asahi Kasei Medical Co., Ltd.
1801 Rockville Pike Suite 300
Rockville,  MD  20852
Applicant Contact DAVID L WEST
Correspondent
Asahi Kasei Medical Co., Ltd.
1801 Rockville Pike Suite 300
Rockville,  MD  20852
Correspondent Contact DAVID L WEST
Regulation Number876.5860
Classification Product Code
KDI  
Date Received09/02/2008
Decision Date 10/03/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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