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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 K871242
FOIA Releasable 510(k) K871242
Device Name REVERSE OSMOSIS WATER PURIFICATION SYSTEM
Applicant
Medro Systems, Inc.
416 E. Industrial Blvd.
Mckinney,  TX  75069
Applicant Contact JOAN C STIVERS
Correspondent
Medro Systems, Inc.
416 E. Industrial Blvd.
Mckinney,  TX  75069
Correspondent Contact JOAN C STIVERS
Regulation Number876.5665
Classification Product Code
FIP  
Date Received03/27/1987
Decision Date 03/16/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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