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 |
|