DRS-4 DIALYZER REPROCESSING SYSTEM

Dialyzer Reprocessing System

SERATRONICS, INC.

The following data is part of a premarket notification filed by Seratronics, Inc. with the FDA for Drs-4 Dialyzer Reprocessing System.

Pre-market Notification Details

Device IDK860674
510k NumberK860674
Device Name:DRS-4 DIALYZER REPROCESSING SYSTEM
ClassificationDialyzer Reprocessing System
Applicant SERATRONICS, INC. 4090 PIKE LN. Concord,  CA  94520
ContactScott N Walker
CorrespondentScott N Walker
SERATRONICS, INC. 4090 PIKE LN. Concord,  CA  94520
Product CodeLIF  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-02-24
Decision Date1986-04-07

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