FDA 510(k) Application Details - K163447

Device Classification Name	More FDA Info for this Device
510(K) Number	K163447
Device Name	Premium Plus Disposable Barrier Sleeve
Applicant	PREMIUM PLUS INTERNATIONAL LIMITED FLAT 1001 YUEN LONG TRADING CENTRE, 33 WANG YIP STREET WEST YUEN LONG N.T. HONG KONG CN Other 510(k) Applications for this Company
Contact	JESSICA MAO Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PEM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/08/2016
Decision Date	06/20/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review