FDA 510(k) Application Details - K201549

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K201549
Device Name	Mask, Surgical
Applicant	Modern Healthcare Corp. NO. 751, Sec. 2, Chung-Chou Rd., Tien-Chung Town, Chang-Hwa County 52045 TW Other 510(k) Applications for this Company
Contact	Ke-Min Jen 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	06/09/2020
Decision Date	08/26/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review