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FDA 510(k) Application Details - K181049
Device Classification Name
Separator, Automated, Blood Cell And Plasma, Therapeutic
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510(K) Number
K181049
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
04/20/2018
Decision Date
11/01/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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