RENAL SYSTEMS PERITONEAL ACCESS SYSTEM

System, Peritoneal, Automatic Delivery

RENAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Renal Systems, Inc. with the FDA for Renal Systems Peritoneal Access System.

Pre-market Notification Details

Device IDK844108
510k NumberK844108
Device Name:RENAL SYSTEMS PERITONEAL ACCESS SYSTEM
ClassificationSystem, Peritoneal, Automatic Delivery
Applicant RENAL SYSTEMS, INC. 14905 28TH AVE. N. Minneapolis,  MN  55441
ContactLeroy J Fischbach
CorrespondentLeroy J Fischbach
RENAL SYSTEMS, INC. 14905 28TH AVE. N. Minneapolis,  MN  55441
Product CodeFKX  
CFR Regulation Number876.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-10-23
Decision Date1985-01-07

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.