FDA 510(k) Application Details - K241186

Device Classification Name	Bone Grafting Material, Synthetic   More FDA Info for this Device
510(K) Number	K241186
Device Name	Bone Grafting Material, Synthetic
Applicant	Shenzhen Dazhou Medical Technology Co., Ltd. St B605, Bldg No.1, Yesun Intelligent Community II, 1301-76 Guanguang Rd., Longhua District Shenzhen 518110 CN Other 510(k) Applications for this Company
Contact	Jingzhou Yang Other 510(k) Applications for this Contact
Regulation Number	872.3930   More FDA Info for this Regulation Number
Classification Product Code	LYC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/29/2024
Decision Date	02/21/2025
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