FDA 510(k) Application Details - K160232

Device Classification Name	More FDA Info for this Device
510(K) Number	K160232
Device Name	Disposable Barrier Sleeves and Covers
Applicant	DENTSPLY International Inc. 221 West Philadephia Street, Suite 60 York, PA 17408 US Other 510(k) Applications for this Company
Contact	Helen Lewis 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	02/01/2016
Decision Date	06/07/2016
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