DIALYZER REPROCESSING SYSTEM DRS-4

Dialyzer Reprocessing System

SERATRONICS, INC.

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

Pre-market Notification Details

Device IDK821863
510k NumberK821863
Device Name:DIALYZER REPROCESSING SYSTEM DRS-4
ClassificationDialyzer Reprocessing System
Applicant SERATRONICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeLIF  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-06-24
Decision Date1982-10-18

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