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FDA 510(k) Application Details - K974127
Device Classification Name
Subsystem, Water Purification
More FDA Info for this Device
510(K) Number
K974127
Device Name
Subsystem, Water Purification
Applicant
AUTOMATA INSTRUMENTATION, INC.
15600 NORTH 78TH ST.
SCOTTSDALE, AZ 85260-1735 US
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Contact
LINDA V MASANO
Other 510(k) Applications for this Contact
Regulation Number
876.5665
More FDA Info for this Regulation Number
Classification Product Code
FIP
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More FDA Info for this Product Code
Date Received
11/03/1997
Decision Date
12/19/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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