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FDA 510(k) Application Details - K994306
Device Classification Name
Accessories, Blood Circuit, Hemodialysis
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510(K) Number
K994306
Device Name
Accessories, Blood Circuit, Hemodialysis
Applicant
MEDISYSTEMS CORP.
1201 3RD AVE.
SUITE 3900
SEATTLE, WA 98101-3016 US
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Contact
FREDRIC G SWINDLER
Other 510(k) Applications for this Contact
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
12/21/1999
Decision Date
03/20/2000
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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