FDA 510(k) Application Details - K190293

Device Classification Name	Brush, Biopsy, Bronchoscope (Non-Rigid)   More FDA Info for this Device
510(K) Number	K190293
Device Name	Brush, Biopsy, Bronchoscope (Non-Rigid)
Applicant	Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi 192-8507 JP Other 510(k) Applications for this Company
Contact	Toshiyuki Nakajima 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	02/11/2019
Decision Date	08/02/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review