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FDA 510(k) Application Details - K141997
Device Classification Name
Accessories, Blood Circuit, Hemodialysis
More FDA Info for this Device
510(K) Number
K141997
Device Name
Accessories, Blood Circuit, Hemodialysis
Applicant
FRESENIUS MEDICAL CARE
920 Winter Street
Waltham, MA 02451 US
Other 510(k) Applications for this Company
Contact
DENISE OPPERMANN
Other 510(k) Applications for this Contact
Regulation Number
876.5820
More FDA Info for this Regulation Number
Classification Product Code
KOC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/23/2014
Decision Date
04/01/2015
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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