FDA 510(k) Application Details - K143727

Device Classification Name	Bronchoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K143727
Device Name	Bronchoscope (Flexible Or Rigid)
Applicant	PENTAX OF AMERICA, INC. 3 PARAGON DRIVE MONTVALE, NJ 07645 US Other 510(k) Applications for this Company
Contact	KRISHNA GOVINDARAJAN Other 510(k) Applications for this Contact
Regulation Number	874.4680   More FDA Info for this Regulation Number
Classification Product Code	EOQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/29/2014
Decision Date	10/29/2015
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