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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 K050603
Device Name OLPUR DIALYZER, MODEL HD 190
Applicant
Nephros, Inc.
3960 Broadway,
New York,  NY  10032
Applicant Contact NADIA C GREENIDGE
Correspondent
Nephros, Inc.
3960 Broadway,
New York,  NY  10032
Correspondent Contact NADIA C GREENIDGE
Regulation Number876.5860
Classification Product Code
KDI  
Date Received03/09/2005
Decision Date 06/09/2005
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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