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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 K031832
Device Name MEGA PURE CART
Applicant
Mega Services
106 Lost Meadows Dr.
Cibolo,  TX  78108
Applicant Contact ROBERT OLIVER
Correspondent
Mega Services
106 Lost Meadows Dr.
Cibolo,  TX  78108
Correspondent Contact ROBERT OLIVER
Regulation Number876.5665
Classification Product Code
FIP  
Date Received06/13/2003
Decision Date 10/20/2004
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
Predetermined Change
Control Plan Authorized		 No
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