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 injection needle, gastroenterology-urology
510(k) Number K982890
Device Name ADVANCED UROSCIENCE INJECTION NEEDLE
Applicant
ADVANCED UROSCIENCE, INC.
1290 HAMMOND RD.
ST. PAUL,  MN  55110
Applicant Contact KAREN E PETERSON
Correspondent
ADVANCED UROSCIENCE, INC.
1290 HAMMOND RD.
ST. PAUL,  MN  55110
Correspondent Contact KAREN E PETERSON
Regulation Number876.1500
Classification Product Code
FBK  
Date Received08/17/1998
Decision Date 10/26/1998
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
-
-