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 clip, implantable
510(k) Number K200166
Device Name Mirus Ligating Clip, Mirus Ligating Clip Applier
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,  IN 396191
Applicant Contact Umesh Sharma
Correspondent
M/s. Meril Endo Surgery Private Limited
Third Floor , E1-E3, Meril Park, Survey No. 135/2/B & 174/2,
Muktanand Marg
Chala, Vapi,  IN 396191
Correspondent Contact Umesh Sharma
Regulation Number878.4300
Classification Product Code
FZP  
Subsequent Product Code
GAG  
Date Received01/22/2020
Decision Date 11/23/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-