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 Dressing, Wound, Drug
510(k) Number K062559
Device Name URGOCELL AG ANTIMICROBIAL WOUND DRESSING WITH SILVER
Applicant
Laboratoires Urgo
42 Rue De Longvic
21300 Chenove,  FR 21300
Applicant Contact SOPHIE FORTIN
Correspondent
Laboratoires Urgo
42 Rue De Longvic
21300 Chenove,  FR 21300
Correspondent Contact SOPHIE FORTIN
Classification Product Code
FRO  
Date Received08/30/2006
Decision Date 01/29/2007
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
-
-