FDA 510(k) Application Details - K974127

Device Classification Name Subsystem, Water Purification

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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
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Regulation Number 876.5665

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Classification Product Code FIP
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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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