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FDA 510(k) Application Details - K222318
Device Classification Name
System, Peritoneal, Automatic Delivery
More FDA Info for this Device
510(K) Number
K222318
Device Name
System, Peritoneal, Automatic Delivery
Applicant
Fresenius Medical Care Renal Therapies Group, LLC
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
876.5630
More FDA Info for this Regulation Number
Classification Product Code
FKX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/02/2022
Decision Date
10/31/2022
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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