FDA 510(k) Application Details - K153701

Device Classification Name	Nasopharyngoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K153701
Device Name	Nasopharyngoscope (Flexible Or Rigid)
Applicant	SOPRO-COMEG GMBH DORNIERSTRASSE 55 TUTTLINGEN 78532 DE Other 510(k) Applications for this Company
Contact	HAROLD LETTAU Other 510(k) Applications for this Contact
Regulation Number	874.4760   More FDA Info for this Regulation Number
Classification Product Code	EOB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/2015
Decision Date	09/09/2016
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