Brush Biopsy Set ; Deflectable Brush Biopsy Set

Endoscopic Cytology Brush

Cook Incorporated

The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Brush Biopsy Set ; Deflectable Brush Biopsy Set.

Pre-market Notification Details

Device IDK182231
510k NumberK182231
Device Name:Brush Biopsy Set ; Deflectable Brush Biopsy Set
ClassificationEndoscopic Cytology Brush
Applicant Cook Incorporated 750 Daniels Way Bloomington,  IN  47404
ContactThomas Palmer
CorrespondentChelsea Woods
Cook Incorporated 750 Daniels Way Bloomington,  IN  47404
Product CodeFDX  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-08-17
Decision Date2019-05-01

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