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FDA 510(k) Application Details - K002816
Device Classification Name
Accessories, Blood Circuit, Hemodialysis
More FDA Info for this Device
510(K) Number
K002816
Device Name
Accessories, Blood Circuit, Hemodialysis
Applicant
TRANSONIC SYSTEMS, INC.
34 DUTCH MILL RD.
ITHACA, NY 14850 US
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Contact
MARK S ALSBERGE
Other 510(k) Applications for this Contact
Regulation Number
876.5820
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Classification Product Code
KOC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/11/2000
Decision Date
11/22/2000
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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