• 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, ureteral
510(k) Number K933941
Device Name MENLO CARE URINARY DIVERSION STENT
Applicant
MENLO CARE, INC.
1350 WILLOW RD.
MENLO PARK,  CA  94025 -1516
Applicant Contact BOB BLEY
Correspondent
MENLO CARE, INC.
1350 WILLOW RD.
MENLO PARK,  CA  94025 -1516
Correspondent Contact BOB BLEY
Regulation Number876.4620
Classification Product Code
FAD  
Date Received08/12/1993
Decision Date 03/31/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-