FDA 510(k) Application Details - K010592

Device Classification Name Subsystem, Water Purification

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510(K) Number K010592
Device Name Subsystem, Water Purification
Applicant AQUA WATER TREATMENT, INC.
8195 EAST BAY BLVD.
NAVARRE, FL 32566 US
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Contact ANTHONY WEATHERS
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Regulation Number 876.5665

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Classification Product Code FIP
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Date Received 02/28/2001
Decision Date 09/28/2001
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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