DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION

System, Peritoneal, Automatic Delivery

DELMED, INC.

The following data is part of a premarket notification filed by Delmed, Inc. with the FDA for Delmed 80/2 Dialysis System W/ultrafiltration.

Pre-market Notification Details

Device IDK901477
510k NumberK901477
Device Name:DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION
ClassificationSystem, Peritoneal, Automatic Delivery
Applicant DELMED, INC. 4090 PIKE LN. Concord,  CA  94520
ContactThomas E Cane
CorrespondentThomas E Cane
DELMED, INC. 4090 PIKE LN. Concord,  CA  94520
Product CodeFKX  
CFR Regulation Number876.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-03-27
Decision Date1990-07-27

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