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 Collector, Urine, (And Accessories) For Indwelling Catheter
510(k) Number K852085
Device Name KENDALL CURITY URINARY OUTPUT MONITOR DRAINAGE BAG
Applicant
THE KENDAL CO.
ONE FEDERAL ST.
BOSTON,  MA  02110 -2003
Applicant Contact MARK W WENZEL
Correspondent
THE KENDAL CO.
ONE FEDERAL ST.
BOSTON,  MA  02110 -2003
Correspondent Contact MARK W WENZEL
Regulation Number876.5250
Classification Product Code
KNX  
Date Received05/13/1985
Decision Date 08/07/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-