FDA 510(k) Application Details - K233203

Device Classification Name	Barrier, Animal Source, Intraoral   More FDA Info for this Device
510(K) Number	K233203
Device Name	Barrier, Animal Source, Intraoral
Applicant	Collagen Matrix, Inc. 15 Thornton Rd. Oakland, NJ 07436 US Other 510(k) Applications for this Company
Contact	Daniel Fernandez 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	09/28/2023
Decision Date	05/01/2024
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