Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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 # 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 # 135/2b & 174/2
Muktanand Marg
Chala, Vapi,  IN 396191
Correspondent Contact Umesh Sharma
Regulation Number878.4010
Classification Product Code
MPN  
Date Received04/05/2023
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
Predetermined Change
Control Plan Authorized		 No
-
-