ENDOSCOPIC CYTOLOGY BRUSHES

Endoscopic Cytology Brush

MILL-ROSE LABORATORY

The following data is part of a premarket notification filed by Mill-rose Laboratory with the FDA for Endoscopic Cytology Brushes.

Pre-market Notification Details

Device IDK791668
510k NumberK791668
Device Name:ENDOSCOPIC CYTOLOGY BRUSHES
ClassificationEndoscopic Cytology Brush
Applicant MILL-ROSE LABORATORY 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFDX  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-08-28
Decision Date1979-10-01

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