FDA 510(k) Application Details - K220920

Device Classification Name	Instrument, Surgical, Non-Powered   More FDA Info for this Device
510(K) Number	K220920
Device Name	Instrument, Surgical, Non-Powered
Applicant	Shenzhen Shineyard Medical Device Co. Ltd. 3F, Changfeng Industrial Block No.3 Liuxian Road, XinÆan BaoÆan District, Shenzhen 518000 CN Other 510(k) Applications for this Company
Contact	Yan Ping Other 510(k) Applications for this Contact
Regulation Number	882.4535   More FDA Info for this Regulation Number
Classification Product Code	HAO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/30/2022
Decision Date	09/07/2022
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