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FDA 510(k) Application Details - K954676
Device Classification Name
Accessories, Blood Circuit, Hemodialysis
More FDA Info for this Device
510(K) Number
K954676
Device Name
Accessories, Blood Circuit, Hemodialysis
Applicant
NISSHO CORP.
7205 CORPORATE CENTER DR.
# 305
MIAMI, FL 33126 US
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Contact
KAELYN HADLEY
Other 510(k) Applications for this Contact
Regulation Number
876.5820
More FDA Info for this Regulation Number
Classification Product Code
KOC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/10/1995
Decision Date
03/04/1997
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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