FDA 510(k) Application Details - K203776

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K203776
Device Name	Mask, Surgical
Applicant	SQ Medical Supplies Inc. 8889 West Olympic Blvd. Suite 1000 Beverly Hills Beverly Hills, CA 90211 US Other 510(k) Applications for this Company
Contact	Jonathan Lim 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	12/28/2020
Decision Date	03/25/2021
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