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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 K042018
Device Name ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM
Applicant
Simply Clean Air & Water, Inc.
28 Shepard Dr.
Newington,  CT  06131
Applicant Contact RAYMOND KOWALEC
Correspondent
Simply Clean Air & Water, Inc.
28 Shepard Dr.
Newington,  CT  06131
Correspondent Contact RAYMOND KOWALEC
Regulation Number876.5665
Classification Product Code
FIP  
Date Received07/27/2004
Decision Date 04/15/2005
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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