FDA 510(k) Application Details - K191448

Device Classification Name	More FDA Info for this Device
510(K) Number	K191448
Device Name	Barrier Sleeves
Applicant	Ivoclar Vivadent, AG Bendererstrasse 2 Schaan FL-9494 LI Other 510(k) Applications for this Company
Contact	Sandra Cakebread 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	05/31/2019
Decision Date	10/08/2019
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