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 K984208
Device Name SILVERLON ISLAND DRESSING, SILVERLON ISLAND PAD
Applicant
Argentum International, LLC
P.O. Box 429
Lakemont,  GA  30552
Applicant Contact A. BART FLICK
Correspondent
Argentum International, LLC
P.O. Box 429
Lakemont,  GA  30552
Correspondent Contact A. BART FLICK
Classification Product Code
FRO  
Date Received11/24/1998
Decision Date 02/22/1999
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-