FDA 510(k) Application Details - K221037

Device Classification Name	More FDA Info for this Device
510(K) Number	K221037
Device Name	TruDi Shaver Blade
Applicant	Acclarent, Inc. 31 Technology Drive, Suite 200 Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	Leena Zalavadia Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PGW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/07/2022
Decision Date	07/20/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review