FDA 510(k) Application Details - K170757

Device Classification Name	Mediastinoscope, Surgical   More FDA Info for this Device
510(K) Number	K170757
Device Name	Mediastinoscope, Surgical
Applicant	Boston-Biomedical Associates 100 Crowley Drive, Suite 216 Marlborough, MA 01752 US Other 510(k) Applications for this Company
Contact	Lauren Baker Other 510(k) Applications for this Contact
Regulation Number	874.4720   More FDA Info for this Regulation Number
Classification Product Code	EWY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/13/2017
Decision Date	07/14/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review