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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
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