FDA 510(k) Application Details - K200452

Device Classification Name	Wax,Bone   More FDA Info for this Device
510(K) Number	K200452
Device Name	Wax,Bone
Applicant	M/s. Meril Endo Surgery Private Limited Third Floor, E1-E3, Meril Park, Survey No. 135/2/B & 174/2, Muktanand Marg Chala, Vapi 396191 IN Other 510(k) Applications for this Company
Contact	Umesh Sharma Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MTJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/24/2020
Decision Date	03/27/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review