SARTORIUS MINISART SM 16596HY

Accessories, Blood Circuit, Hemodialysis

SARTORIUS FILTERS, INC.

The following data is part of a premarket notification filed by Sartorius Filters, Inc. with the FDA for Sartorius Minisart Sm 16596hy.

Pre-market Notification Details

Device IDK844504
510k NumberK844504
Device Name:SARTORIUS MINISART SM 16596HY
ClassificationAccessories, Blood Circuit, Hemodialysis
Applicant SARTORIUS FILTERS, INC. 26575 CORPORATE AVE. Hayward,  CA  94545
ContactSteven Cates
CorrespondentSteven Cates
SARTORIUS FILTERS, INC. 26575 CORPORATE AVE. Hayward,  CA  94545
Product CodeKOC  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-11-20
Decision Date1985-01-18

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