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 Stent, Colonic, Metallic, Expandable
510(k) Number K990034
Device Name WILSON-COOK COLONIC Z-STENT
Applicant
Med Institute, Inc.
1400 Cumberland Ave.
P.O. Box 2402
West Lafayette,  IN  47906
Applicant Contact NEAL E FEARNOT
Correspondent
Med Institute, Inc.
1400 Cumberland Ave.
P.O. Box 2402
West Lafayette,  IN  47906
Correspondent Contact NEAL E FEARNOT
Regulation Number878.3610
Classification Product Code
MQR  
Date Received01/06/1999
Decision Date 04/17/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-