FDA 510(k) Application Details - K182927

Device Classification Name	Brush, Biopsy, Bronchoscope (Non-Rigid)   More FDA Info for this Device
510(K) Number	K182927
Device Name	Brush, Biopsy, Bronchoscope (Non-Rigid)
Applicant	Hobbs Medical, Inc. 8 Spring Street Stafford Springs, CT 06076 US Other 510(k) Applications for this Company
Contact	Carlos O. Acosta Other 510(k) Applications for this Contact
Regulation Number	874.4680   More FDA Info for this Regulation Number
Classification Product Code	BTG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/22/2018
Decision Date	02/07/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review