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 catheter, urological
510(k) Number K860484
Device Name CURITY & KENGUARD SILICONE COATED FOLEY CATHETER
Applicant
THE KENDAL CO.
ONE FEDERAL ST.
BOSTON,  MA  02110 -2003
Applicant Contact CHRISTINE MORGIDA
Correspondent
THE KENDAL CO.
ONE FEDERAL ST.
BOSTON,  MA  02110 -2003
Correspondent Contact CHRISTINE MORGIDA
Regulation Number876.5130
Classification Product Code
KOD  
Date Received02/10/1986
Decision Date 03/11/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-