FDA 510(k) Application Details - K191987

Device Classification Name	Oral Wound Dressing   More FDA Info for this Device
510(K) Number	K191987
Device Name	Oral Wound Dressing
Applicant	Forward Science 10401 Greenbough, Ste 100 Stafford, TX 77477 US Other 510(k) Applications for this Company
Contact	Brian Pikkula 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	07/25/2019
Decision Date	11/27/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review