FDA 510(k) Application Details - K031502

Device Classification Name Tank, Holding, Dialysis

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510(K) Number K031502
Device Name Tank, Holding, Dialysis
Applicant USFILTER
725 WOOTEN RD.
COLORADO SPRINGS, CO 80915 US
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Contact EDWARD L ARMSTRONG
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Regulation Number 876.5820

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Classification Product Code FIN
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Date Received 05/13/2003
Decision Date 08/27/2004
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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