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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 K002512
Device Name TORAYSULFONE DIALYZER
Applicant
Toray Industries (America), Inc.
540 College St.
Bellaire,  TX  77401 -5010
Applicant Contact LISA S JONES
Correspondent
Toray Industries (America), Inc.
540 College St.
Bellaire,  TX  77401 -5010
Correspondent Contact LISA S JONES
Regulation Number876.5860
Classification Product Code
KDI  
Date Received08/15/2000
Decision Date 10/15/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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