510(k) K033118

BIPRO MODEL SDS-CB200 by Medical Solutions International — Product Code FIN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2004
Date Received
September 30, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tank, Holding, Dialysis
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type