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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 K001811
Device Name NEU-ION HEMODIALYIS WATER TREATMENT SYSTEM
Applicant
Neu-Ion, Inc.
7200 Rutherford Rd.
Suite 100
Baltimore,  MD  21244 -2704
Applicant Contact LEE A HEIKKINEN
Correspondent
Neu-Ion, Inc.
7200 Rutherford Rd.
Suite 100
Baltimore,  MD  21244 -2704
Correspondent Contact LEE A HEIKKINEN
Regulation Number876.5665
Classification Product Code
FIP  
Date Received06/15/2000
Decision Date 10/25/2000
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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