FDA 510(k) Application Details - K221606

Device Classification Name	Cover, Burr Hole   More FDA Info for this Device
510(K) Number	K221606
Device Name	Cover, Burr Hole
Applicant	Chendu MedArt Medical Scientific Co., Ltd. No. 102, Tianying Road, Chengdu High-tech Industrial Development Zone Chengdu 611731 CN Other 510(k) Applications for this Company
Contact	Huaping Ran Other 510(k) Applications for this Contact
Regulation Number	882.5250   More FDA Info for this Regulation Number
Classification Product Code	GXR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/02/2022
Decision Date	11/21/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review