FDA 510(k) Application Details - K020103

Device Classification Name Accessories, Blood Circuit, Hemodialysis

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510(K) Number K020103
Device Name Accessories, Blood Circuit, Hemodialysis
Applicant STIHLER ELECTRONIC GMBH
30 NORTHPORT RD.
SOUND BEACH, NY 11789-1734 US
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Contact RICHARD C LANZILLOTO
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Regulation Number 876.5820

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Classification Product Code KOC
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Date Received 01/11/2002
Decision Date 07/24/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Statement
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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