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 Mesh, Surgical, Polymeric
510(k) Number K133889
Device Name PREMIUM
Applicant
Cousin Biotech Sas
8 Rue De L Abbe Bonpain
Allee Des Roses
Wervicq-Sud,  FR 59117
Applicant Contact FRANCK PELLETIER
Correspondent
Cousin Biotech Sas
8 Rue De L Abbe Bonpain
Allee Des Roses
Wervicq-Sud,  FR 59117
Correspondent Contact FRANCK PELLETIER
Regulation Number878.3300
Classification Product Code
FTL  
Date Received12/20/2013
Decision Date 09/04/2014
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
-
-