FRESENIUS AS 104 CELL SEPARATOR

Separator, Automated, Blood Cell And Plasma, Therapeutic

FRESENIUS USA, INC.

The following data is part of a premarket notification filed by Fresenius Usa, Inc. with the FDA for Fresenius As 104 Cell Separator.

Pre-market Notification Details

Device IDK895435
510k NumberK895435
Device Name:FRESENIUS AS 104 CELL SEPARATOR
ClassificationSeparator, Automated, Blood Cell And Plasma, Therapeutic
Applicant FRESENIUS USA, INC. 4090 PIKE LN. Concord,  CA  94520
ContactGarry J Vibert
CorrespondentGarry J Vibert
FRESENIUS USA, INC. 4090 PIKE LN. Concord,  CA  94520
Product CodeLKN  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-09-07
Decision Date1990-11-02

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