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 Bandage, Liquid
510(k) Number K990955
Device Name MODIFICATION OF:BIODERM FOAM WOUND DRESSING
Applicant
BIODERM, INC.
P.O. BOX 4882
WHEATON,  IL  60189
Applicant Contact GEORGE WORTHLEY
Correspondent
BIODERM, INC.
P.O. BOX 4882
WHEATON,  IL  60189
Correspondent Contact GEORGE WORTHLEY
Regulation Number880.5090
Classification Product Code
KMF  
Date Received03/22/1999
Decision Date 05/18/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-