FDA 510(k) Application Details - K160337

Device Classification Name	More FDA Info for this Device
510(K) Number	K160337
Device Name	Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns
Applicant	BAM CORPORATION LIMITED NO. 138 SHATIN RURAL COMMITTEE ROAD, SHATIN, N.T. UNIT 1706, TOWER 2, GRAND CENTRAL PLAZA HONG KONG CN Other 510(k) Applications for this Company
Contact	MARY MEJAES Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QPC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/08/2016
Decision Date	07/07/2017
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