FDA 510(k) Application Details - K243457

Device Classification Name	Dressing, Wound, Drug   More FDA Info for this Device
510(K) Number	K243457
Device Name	Dressing, Wound, Drug
Applicant	Seriously Clean, Ltd 1075 W. Kathryn St. Suite 6 Nixa, MO 65714 US Other 510(k) Applications for this Company
Contact	Kip Glass 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	11/07/2024
Decision Date	05/02/2025
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