FDA 510(k) Application Details - K201604

Device Classification Name	More FDA Info for this Device
510(K) Number	K201604
Device Name	Plasdent Disposable Barrier Sleeves and Barrier Film
Applicant	Plasdent Corporation 969 Price Street Pomona, CA 91767 US Other 510(k) Applications for this Company
Contact	Belen G Walayat 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	06/15/2020
Decision Date	12/23/2020
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