DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD

System, Dialysate Delivery, Central Multiple Patient

RENAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Renal Systems, Inc. with the FDA for Dialysate Concentrate For Hemodialysis-liquid/powd.

Pre-market Notification Details

• Device ID: K843963
• 510k Number: K843963
• Device Name: DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD
• Classification: System, Dialysate Delivery, Central Multiple Patient
• Applicant: RENAL SYSTEMS, INC. 14905 28TH AVE. N. Minneapolis, MN 55441
• Contact: Leroy J Fischbach
• Correspondent: Leroy J Fischbach; RENAL SYSTEMS, INC. 14905 28TH AVE. N. Minneapolis, MN 55441
• Product Code: FKQ
• CFR Regulation Number: 876.5820 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1984-10-11
• Decision Date: 1985-01-07

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30677964000301	K843963	000
30677964000561	K843963	000
30677964000578	K843963	000
30677964000585	K843963	000
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10850001011058	K843963	000