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, Polyethylene
510(k) Number K220219
Device Name PERMALOOP Suture, PERMATAPE Suture
Applicant
Medos International SARL
Chemin-Blanc 38, Case Postale
Le Locle,  CH Ch 2400
Applicant Contact Ashley Aromando (Goncalo)
Correspondent
Depuy Synthes Mitek Sports Medicine
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact Ashley Aromando (Goncalo)
Regulation Number878.5000
Classification Product Code
GAT  
Date Received01/26/2022
Decision Date 04/26/2022
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
Predetermined Change
Control Plan Authorized		 No
-
-