FDA 510(k) Application Details - K231410

Device Classification Name Subsystem, Water Purification

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510(K) Number K231410
Device Name Subsystem, Water Purification
Applicant Evoqua Water Technologies LLC
558 Clark Road
Tewksbury, MA 01876 US
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Contact Robert Dudek
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Regulation Number 876.5665

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Classification Product Code FIP
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Date Received 05/15/2023
Decision Date 07/19/2023
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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