Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K023509
Device Classification Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
More FDA Info for this Device
510(K) Number
K023509
Device Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant
DAVITA CLINICAL RESEARCH (TRRI)
4050 OLSON MEMORIAL HWY
MINNEAPOLIS, MN 55422 US
Other 510(k) Applications for this Company
Contact
TRACY L GRAY
Other 510(k) Applications for this Contact
Regulation Number
876.5860
More FDA Info for this Regulation Number
Classification Product Code
KDI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/18/2002
Decision Date
10/30/2003
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact