• 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 dilator, catheter, ureteral
510(k) Number K942578
Device Name ENTRAC URETERAL BALLOON DILATATION CATHETERS
Applicant
AMERICAN MEDICAL SYSTEMS, INC.
11001 BREN RD. EAST
MINNETONKA,  MN  55343
Applicant Contact SYLVIA L GUBBE
Correspondent
AMERICAN MEDICAL SYSTEMS, INC.
11001 BREN RD. EAST
MINNETONKA,  MN  55343
Correspondent Contact SYLVIA L GUBBE
Regulation Number876.5470
Classification Product Code
EZN  
Date Received05/31/1994
Decision Date 08/19/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-