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 Endoscopic Cytology Brush
510(k) Number K040324
Device Name WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSH
Applicant
Wilson-Cook Medical, Inc.
4900 Bethania Station Rd.
Winston-Salem,  NC  27105
Applicant Contact MARGE WALLS-WALKER
Correspondent
Wilson-Cook Medical, Inc.
4900 Bethania Station Rd.
Winston-Salem,  NC  27105
Correspondent Contact MARGE WALLS-WALKER
Regulation Number876.1500
Classification Product Code
FDX  
Date Received02/10/2004
Decision Date 05/20/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-