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 K060804
Device Name COLLAGRAN-COLLAGEN WOUND DRESSING, COLLAGRANAG-COLLAGEN W/SILVER ANTIMICROBIAL WOUND DRESSING
Applicant
COVALON TECHNOLOGIES LTD.
2033 IVERSON LANES
WAXHAW,  NC  28173
Applicant Contact JACQUES LEMMETTI
Correspondent
COVALON TECHNOLOGIES LTD.
2033 IVERSON LANES
WAXHAW,  NC  28173
Correspondent Contact JACQUES LEMMETTI
Classification Product Code
FRO  
Date Received03/24/2006
Decision Date 04/18/2006
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product Yes
Recalls CDRH Recalls
-
-