FDA.report

510(k) K200166

Device
Mirus Ligating Clip, Mirus Ligating Clip Applier
Applicant
M/s. Meril Endo Surgery Private Limited.
510(k) number
K200166
Product code
FZP
Decision
Substantially Equivalent (SESE)
Decision date
2020-11-23
Date received
2020-01-22
Regulation
878.4300
Classification name
Clip, Implantable
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Umesh Sharma
Address
Third Floor, E1-E3, Meril Park, Survey # 135/2/B & 174/2, Muktanand Marg Chala, Vapi IN 396191 396191

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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