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FDA 510(k) Application Details - K982134
Device Classification Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
More FDA Info for this Device
510(K) Number
K982134
Device Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant
DYNAMIC TECHNOLOGY CORP.
SCIENCE-BASED INDUSTRIAL PARK
HSINCHU 300 TW
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Contact
YAW C YANG
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Regulation Number
876.5860
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Classification Product Code
KDI
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More FDA Info for this Product Code
Date Received
06/17/1998
Decision Date
04/14/1999
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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