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 Suture, Nonabsorbable, Synthetic, Polypropylene
510(k) Number K211178
Device Name DURAMESH Mesh Suture
Applicant
Msi
One Magnificent Mile
980 N. Lake Shore Dr., Suite 1400
Chicago,  IL  60611
Applicant Contact Greg Dumanian
Correspondent
Msi
One Magnificent Mile
980 N. Lake Shore Dr., Suite 1400
Chicago,  IL  60611
Correspondent Contact Greg Dumanian
Regulation Number878.5010
Classification Product Code
GAW  
Date Received04/20/2021
Decision Date 09/02/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT03940560
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-