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 tubes, gastrointestinal (and accessories)
510(k) Number K842808
Device Name URITROL-M
Applicant
THE WASHINGTON GROUP, INC.
P.O. BOX 790875
DALLAS,  TX  75379 -
Applicant Contact DOUGLAS WASHINGTON
Correspondent
THE WASHINGTON GROUP, INC.
P.O. BOX 790875
DALLAS,  TX  75379 -
Correspondent Contact DOUGLAS WASHINGTON
Regulation Number876.5980
Classification Product Code
KNT  
Date Received07/18/1984
Decision Date 11/16/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-