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 K945832
Device Name BRADY MEDICAL PRODUCTS TRANSCORBENT AND THINSITE TOPICAL BORDER WOUND DRESSINGS
Applicant
Brady Medical Products Co.
727 W. Glendale Ave.
P.O. Box 571
Milwaukee,  WI  53201
Applicant Contact DIANE HOCHREIN
Correspondent
Brady Medical Products Co.
727 W. Glendale Ave.
P.O. Box 571
Milwaukee,  WI  53201
Correspondent Contact DIANE HOCHREIN
Regulation Number878.4022
Classification Product Code
NAE  
Date Received11/29/1994
Decision Date 03/01/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-