FDA 510(k) Application Details - K033118

Device Classification Name Tank, Holding, Dialysis

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510(K) Number K033118
Device Name Tank, Holding, Dialysis
Applicant MEDICAL SOLUTIONS INTERNATIONAL
11522 W 90TH ST.
OVERLAND PARK, KS 66214 US
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Contact JACK DILLON
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Regulation Number 876.5820

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Classification Product Code FIN
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Date Received 09/30/2003
Decision Date 06/28/2004
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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