FDA 510(k) Application Details - K160269

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K160269
Device Name	Mask, Surgical
Applicant	SAN-M PACKAGE CO., LTD. 1086-1 Ojiro Shimada-City 428-8652 JP Other 510(k) Applications for this Company
Contact	Shogo Nagao 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	02/02/2016
Decision Date	09/06/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review