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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 K931595
Device Name REVERSE OSMOSIS EQUIPMENT FOR WATER PURIFICATION
Applicant
OSMONICS, INC.
5951 CLEARWATER DR.
MINNETONKA,  MN  55343
Applicant Contact MARK A PAULSON
Correspondent
OSMONICS, INC.
5951 CLEARWATER DR.
MINNETONKA,  MN  55343
Correspondent Contact MARK A PAULSON
Regulation Number876.5665
Classification Product Code
FIP  
Date Received03/31/1993
Decision Date 12/29/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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