Pulmonary Cytology Brush

Brush, Biopsy, Bronchoscope (non-rigid)

Hobbs Medical, Inc.

The following data is part of a premarket notification filed by Hobbs Medical, Inc. with the FDA for Pulmonary Cytology Brush.

Pre-market Notification Details

Device IDK182927
510k NumberK182927
Device Name:Pulmonary Cytology Brush
ClassificationBrush, Biopsy, Bronchoscope (non-rigid)
Applicant Hobbs Medical, Inc. 8 Spring Street Stafford Springs,  CT  06076
ContactCarlos O. Acosta
CorrespondentCarlos O. Acosta
Hobbs Medical, Inc. 8 Spring Street Stafford Springs,  CT  06076
Product CodeBTG  
CFR Regulation Number874.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyEar Nose & Throat
510k Review PanelAnesthesiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-10-22
Decision Date2020-02-07

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