FDA 510(k) Application Details - K231305

Device Classification Name	Barrier, Animal Source, Intraoral   More FDA Info for this Device
510(K) Number	K231305
Device Name	Barrier, Animal Source, Intraoral
Applicant	Aroa Biosurgery Ltd. 2 Kingsford Smith Place Airport Oaks Auckland 2022 NZ Other 510(k) Applications for this Company
Contact	Tina O'Brien Other 510(k) Applications for this Contact
Regulation Number	872.3930   More FDA Info for this Regulation Number
Classification Product Code	NPL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/05/2023
Decision Date	01/23/2024
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