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FDA 510(k) Application Details - K082758
Device Classification Name
Accessories, Blood Circuit, Hemodialysis
More FDA Info for this Device
510(K) Number
K082758
Device Name
Accessories, Blood Circuit, Hemodialysis
Applicant
STIHLER ELECTRONIC GMBH
30 NORTHPORT RD.
SOUND BEACH, NY 11789-1734 US
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Contact
STEPHEN T MLCOCH
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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
09/19/2008
Decision Date
12/19/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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