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FDA 510(k) Application Details - K123630
Device Classification Name
System, Peritoneal, Automatic Delivery
More FDA Info for this Device
510(K) Number
K123630
Device Name
System, Peritoneal, Automatic Delivery
Applicant
FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE
920 WINTER ST
WALTHAM, MA 02451 US
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Contact
DENISE OPPERMANN
Other 510(k) Applications for this Contact
Regulation Number
876.5630
More FDA Info for this Regulation Number
Classification Product Code
FKX
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More FDA Info for this Product Code
Date Received
11/23/2012
Decision Date
09/09/2013
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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