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 K070581
Device Name SILVER ALGINATE II WOUND DRESSING
Applicant
Advanced Medical Solutions Limited
Rd. Three
Winsford Industrial Estate
Winsford, Cheshire,  GB CW7 3PD
Applicant Contact GRAHAME SOMERVILLE
Correspondent
Advanced Medical Solutions Limited
Rd. Three
Winsford Industrial Estate
Winsford, Cheshire,  GB CW7 3PD
Correspondent Contact GRAHAME SOMERVILLE
Classification Product Code
FRO  
Date Received03/01/2007
Decision Date 07/13/2007
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
-
-