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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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More FDA Info for this Product Code
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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