FDA 510(k) Application Details - K221184

Device Classification Name	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece   More FDA Info for this Device
510(K) Number	K221184
Device Name	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Applicant	Bien-Air Surgery SA Rue de l'Ouest 2b Le Noirmont 2340 CH Other 510(k) Applications for this Company
Contact	Jonas Guerdat Other 510(k) Applications for this Contact
Regulation Number	874.4250   More FDA Info for this Regulation Number
Classification Product Code	ERL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/25/2022
Decision Date	11/02/2022
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