FDA 510(k) Application Details - K241283

Device Classification Name	Oral Wound Dressing   More FDA Info for this Device
510(K) Number	K241283
Device Name	Oral Wound Dressing
Applicant	Zinkh NV Zuiderlaan 1-3 PO box: 8 Gent 9000 BE Other 510(k) Applications for this Company
Contact	Emiel Lippens 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	05/07/2024
Decision Date	01/03/2025
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