FDA 510(k) Application Details - K223669

Device Classification Name	Sealant, Microbial   More FDA Info for this Device
510(K) Number	K223669
Device Name	Sealant, Microbial
Applicant	Adhezion Biomedical, LLC. 506 Pine Mountain Rd. Hudson, NC 28638 US Other 510(k) Applications for this Company
Contact	Richard Jones Other 510(k) Applications for this Contact
Regulation Number	878.4370   More FDA Info for this Regulation Number
Classification Product Code	NZP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/07/2022
Decision Date	06/12/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review