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FDA 510(k) Application Details - K964264
Device Classification Name
System, Dialysate Delivery, Single Patient
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510(K) Number
K964264
Device Name
System, Dialysate Delivery, Single Patient
Applicant
INTEGRATED BIOMEDICAL TECHNOLOGY, INC.
2931 MOOSE TRAIL
ELKHART, IN 46514 US
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Contact
WEN H WU
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Regulation Number
876.5820
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Classification Product Code
FKP
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More FDA Info for this Product Code
Date Received
10/25/1996
Decision Date
06/16/1997
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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