FDA 510(k) Application Details - K181838

Device Classification Name	Instrument, Ent Manual Surgical   More FDA Info for this Device
510(K) Number	K181838
Device Name	Instrument, Ent Manual Surgical
Applicant	3NT Medical Ltd. 22 Hamelacha Street PO Box 11384 Rosh Ha'ayin 4809169 IL Other 510(k) Applications for this Company
Contact	Ehud Bendory Other 510(k) Applications for this Contact
Regulation Number	874.4420   More FDA Info for this Regulation Number
Classification Product Code	LRC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/10/2018
Decision Date	12/20/2018
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