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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 K964539
Device Name PORTABLE SERIES REVERSE OSMOSIS SYSTEMS 700, 701, 702, 703, 704, 750, MRE-NF, F800-F802, RO SECURA, REVERSE OSMOSIS SYST
Applicant
Zyzatech Water Systems, Inc.
7848 S. 202nd St.
Kent,  WA  98032
Applicant Contact JOHN MILLER
Correspondent
Zyzatech Water Systems, Inc.
7848 S. 202nd St.
Kent,  WA  98032
Correspondent Contact JOHN MILLER
Regulation Number876.5665
Classification Product Code
FIP  
Date Received11/12/1996
Decision Date 11/26/1997
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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