FDA 510(k) Application Details - K230258

Device Classification Name	Instrument, Ent Manual Surgical   More FDA Info for this Device
510(K) Number	K230258
Device Name	Instrument, Ent Manual Surgical
Applicant	Excelent Inc. 68 TW Alexander Drive PO Box 13628 Research Triangle Park Durham, NC 27709 US Other 510(k) Applications for this Company
Contact	Kashif Mazhar 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	01/31/2023
Decision Date	05/25/2023
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