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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 K934848
Device Name MASTER ALERT
Applicant
MASTER HYDRO SYSTEMS, INC.
4500 SOUTH BROADWAY
WICHITA,  KS  67216
Applicant Contact J. M. GREENING
Correspondent
MASTER HYDRO SYSTEMS, INC.
4500 SOUTH BROADWAY
WICHITA,  KS  67216
Correspondent Contact J. M. GREENING
Regulation Number876.5665
Classification Product Code
FIP  
Date Received10/21/1993
Decision Date 09/29/1994
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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