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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name subsystem, water purification
510(k) Number K993520
Device Name H20NLY COMPLETE WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
Applicant
SERV-A-PURE CO.
1101 COLUMBUS AVE.
BAY CITY,  MI  48708
Applicant Contact RICHARD C HERZBERGER
Correspondent
SERV-A-PURE CO.
1101 COLUMBUS AVE.
BAY CITY,  MI  48708
Correspondent Contact RICHARD C HERZBERGER
Regulation Number876.5665
Classification Product Code
FIP  
Date Received10/18/1999
Decision Date 05/03/2000
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
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