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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialyzer Reprocessing System
510(k) Number K853413
Device Name RENNEW-D SPORICIDE/DISINFECTANT FOR HEMODIALYZERS
Applicant
Alcide Corp.
One Willard Rd.
Norwalk,  CT  06851
Applicant Contact HARRY M KAUFMAN
Correspondent
Alcide Corp.
One Willard Rd.
Norwalk,  CT  06851
Correspondent Contact HARRY M KAUFMAN
Regulation Number876.5820
Classification Product Code
LIF  
Date Received08/14/1985
Decision Date 09/06/1985
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
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