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FDA 510(k) Application Details - K964539
Device Classification Name
Subsystem, Water Purification
More FDA Info for this Device
510(K) Number
K964539
Device Name
Subsystem, Water Purification
Applicant
ZYZATECH WATER SYSTEMS, INC.
7848 S. 202ND ST.
KENT, WA 98032 US
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Contact
JOHN MILLER
Other 510(k) Applications for this Contact
Regulation Number
876.5665
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Classification Product Code
FIP
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More FDA Info for this Product Code
Date Received
11/12/1996
Decision Date
11/26/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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