FDA 510(k) Application Details - K152197

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K152197
Device Name	Mask, Surgical
Applicant	Skypro Medical Supplies Company C301, Tsing Yi Industrial Centre Phase 2, 1-33 Cheung Tat 1-33 Cheung Tat Road, Tsing Yi, NT Hong Kong CN Other 510(k) Applications for this Company
Contact	Cyrus Wong 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	08/05/2015
Decision Date	08/26/2016
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