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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Water Purification, General Medical Use
510(k) Number K012716
Device Name MAINSTREAM WATER PURIFICATION DEVICE
Applicant
Prismedical Corp.
1100 Trancas St., Suite 250
Napa,  CA  94558
Applicant Contact ELAINE ALAMBRA
Correspondent
Prismedical Corp.
1100 Trancas St., Suite 250
Napa,  CA  94558
Correspondent Contact ELAINE ALAMBRA
Regulation Number876.5665
Classification Product Code
NHV  
Date Received08/15/2001
Decision Date 05/07/2002
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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