FDA.reportPublic FDA data

510(k) K230981

Device
Meriglu Topical Skin Adhesive
Applicant
M/s. Meril Endo Surgery Private Limited.
510(k) number
K230981
Product code
MPN
Decision
Substantially Equivalent (SESE)
Decision date
2024-03-16
Date received
2023-04-05
Regulation
878.4010
Classification name
Tissue Adhesive For The Topical Approximation Of Skin
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

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

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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