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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 K030652
Device Name MEDRO SPD
Applicant
U.S. FILTER/IONPURE, INC.
10 TECHNOLOGY DR.
LOWELL,  MA  01851
Applicant Contact ROBERT DUDEK
Correspondent
U.S. FILTER/IONPURE, INC.
10 TECHNOLOGY DR.
LOWELL,  MA  01851
Correspondent Contact ROBERT DUDEK
Regulation Number876.5665
Classification Product Code
FIP  
Date Received02/28/2003
Decision Date 09/03/2003
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
Recalls CDRH Recalls
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