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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
Model 13SX,15SX,18SX,21SX,25SX,13LX,15LX,18LX,21LX
Device Name ASAHI REXEED-SX/LX SERIES DIALYZER
Applicant
ASAHI KASEI MEDICAL CO., LTD.
154 main street, ste 2
charlestown,  NH  03603
Contact patsy trisler
Regulation Number876.5860
Classification Product Code
KDI  
Date Received05/11/2012
Decision Date 02/06/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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