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FDA 510(k) Application Details - K172590
Device Classification Name
Separator, Automated, Blood Cell And Plasma, Therapeutic
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510(K) Number
K172590
Device Name
Separator, Automated, Blood Cell And Plasma, Therapeutic
Applicant
Terumo BCT, Inc.
10811 W. Collins Avenue
Lakewood, CO 80215 US
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Contact
Nicholas Wong
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LKN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/29/2017
Decision Date
03/02/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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