FDA 510(k) Application Details - K003560

Device Classification Name Tank, Holding, Dialysis

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510(K) Number K003560
Device Name Tank, Holding, Dialysis
Applicant MAR COR SERVICES, INC.
364 MAPLE AVE.
HARLEYSVILLE, PA 19438 US
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Contact MICHAEL ROBERTSON
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Regulation Number 876.5820

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Classification Product Code FIN
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Date Received 11/17/2000
Decision Date 06/08/2001
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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