FDA 510(k) Application Details - K193336

Device Classification Name	Oral Wound Dressing   More FDA Info for this Device
510(K) Number	K193336
Device Name	Oral Wound Dressing
Applicant	Synedgen, Inc. 1420 North Claremont Blvd. Suite 105D Claremont, CA 91711 US Other 510(k) Applications for this Company
Contact	Shenda Baker Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	OLR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/02/2019
Decision Date	05/27/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review