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FDA 510(k) Application Details - K022412
Device Classification Name
Set, Administration, For Peritoneal Dialysis, Disposable
More FDA Info for this Device
510(K) Number
K022412
Device Name
Set, Administration, For Peritoneal Dialysis, Disposable
Applicant
FRESENIUS MEDICAL CARE NORTH AMERICA
95 HAYDEN AVE.
LEXINGTON, MA 02420-9192 US
Other 510(k) Applications for this Company
Contact
ARTHUR E EILINSFELD
Other 510(k) Applications for this Contact
Regulation Number
876.5630
More FDA Info for this Regulation Number
Classification Product Code
KDJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/24/2002
Decision Date
03/05/2003
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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