FDA 510(k) Application Details - K182725

Device Classification Name	Dressing, Wound, Drug   More FDA Info for this Device
510(K) Number	K182725
Device Name	Dressing, Wound, Drug
Applicant	SweetBio, Inc 20 Dudley Street, Suite 900 Memphis, TN 38103-4904 US Other 510(k) Applications for this Company
Contact	Kayla Graff Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	FRO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2018
Decision Date	05/31/2019
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