FDA 510(k) Application Details - K171320

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K171320
Device Name	Plate, Fixation, Bone
Applicant	Meril Healthcare Pvt. Ltd. First Floor, H1-H3, 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	888.3030   More FDA Info for this Regulation Number
Classification Product Code	HRS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/04/2017
Decision Date	03/08/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review