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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 K013677
Device Name MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM
Applicant
Usfilter/Ionpure, Inc.
10 Technology Dr.
Lowell,  MA  01851
Applicant Contact DAVID A DENTINO
Correspondent
Usfilter/Ionpure, Inc.
10 Technology Dr.
Lowell,  MA  01851
Correspondent Contact DAVID A DENTINO
Regulation Number876.5665
Classification Product Code
FIP  
Date Received11/07/2001
Decision Date 03/08/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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