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, Hydrogel Without Drug And/Or Biologic
510(k) Number K951166
Device Name BIODERM MEDICAL HYDROGEL ISLAND 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 Number878.4022
Classification Product Code
NAE  
Date Received03/14/1995
Decision Date 06/21/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-