FDA 510(k) Application Details - K222549

Device Classification Name	Barrier, Synthetic, Intraoral   More FDA Info for this Device
510(K) Number	K222549
Device Name	Barrier, Synthetic, Intraoral
Applicant	Purgo Biologics Inc. #812, 27 Dunchon-daero 457beon-gil, Jungwon-gu Seongnam-si 13219 KR Other 510(k) Applications for this Company
Contact	Byungsun Kim Other 510(k) Applications for this Contact
Regulation Number	872.3930   More FDA Info for this Regulation Number
Classification Product Code	NPK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/23/2022
Decision Date	05/11/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review