Device Classification Name |
Tissue Adhesive For The Topical Approximation Of Skin
|
510(k) Number |
K230981 |
Device Name |
Meriglu Topical Skin Adhesive |
Applicant |
M/s Meril Endo Surgery Private Limited |
Third Floor, E1-E3, Meril Park Survey No. 135/2B & 174/2 |
Muktanand Marg |
Chala, Vapi,
IN
396191
|
|
Applicant Contact |
Umesh Sharma |
Correspondent |
M/s Meril Endo Surgery Private Limited |
Third Floor, E1-E3, Meril Park Survey No. 135/2B & 174/2 |
Muktanand Marg |
Chala, Vapi,
IN
396191
|
|
Correspondent Contact |
Umesh Sharma |
Regulation Number | 878.4010
|
Classification Product Code |
|
Date Received | 04/05/2023 |
Decision Date | 03/16/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|