FDA 510(k) Application Details - K214094

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K214094
Device Name	Mask, Surgical
Applicant	ROKI Co., Ltd. 2396 Futamata, Futamata-Cho, Tenryu-ku Hamamatsu-shi 431-3314 JP Other 510(k) Applications for this Company
Contact	Takamasa Murata 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	12/28/2021
Decision Date	02/24/2022
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