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FDA 510(k) Application Details - K050273
Device Classification Name
Separator, Automated, Blood Cell And Plasma, Therapeutic
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510(K) Number
K050273
Device Name
Separator, Automated, Blood Cell And Plasma, Therapeutic
Applicant
FRESENIUS MEDICAL CARE NORTH AMERICA
95 HAYDEN AVE.
LEXINGTON, MA 02420-9192 US
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Contact
JANET KAY
Other 510(k) Applications for this Contact
Regulation Number
000.0000
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Classification Product Code
LKN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/07/2005
Decision Date
06/08/2005
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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