FDA 510(k) Application Details - K230645

Device Classification Name	Drape, Surgical   More FDA Info for this Device
510(K) Number	K230645
Device Name	Drape, Surgical
Applicant	Avery Dennison Medical Ltd. IDA Business Park, Ballinalee Road Longford N39 RC80 IE Other 510(k) Applications for this Company
Contact	Lisa Bartakovics Other 510(k) Applications for this Contact
Regulation Number	878.4370   More FDA Info for this Regulation Number
Classification Product Code	KKX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/08/2023
Decision Date	10/25/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review