FDA 510(k) Application Details - K213228

Device Classification Name	Drills, Burrs, Trephines & Accessories (Compound, Powered)   More FDA Info for this Device
510(K) Number	K213228
Device Name	Drills, Burrs, Trephines & Accessories (Compound, Powered)
Applicant	EMD Endoszkop Muszer Gyarto es Kereskedelmi Kft. Bartok Bela u. 113/B Debrecen 4031 HU Other 510(k) Applications for this Company
Contact	Gyula Ujvari Other 510(k) Applications for this Contact
Regulation Number	882.4305   More FDA Info for this Regulation Number
Classification Product Code	HBF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2021
Decision Date	06/20/2022
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