FDA 510(k) Application Details - K220876

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K220876
Device Name	Mask, Surgical
Applicant	AOK Tooling Limited Flat 2009, 20/F, Kowloon Plaza, No.485, Castle Peak Road Cheung Sha Wan, Kowloon 518122 CN Other 510(k) Applications for this Company
Contact	Francis Nithyananthan Other 510(k) Applications for this Contact
Regulation Number	878.4040   More FDA Info for this Regulation Number
Classification Product Code	FXX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/25/2022
Decision Date	07/27/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review