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 K852619
Device Name URI-SURE
Applicant
Ashai Co. , Ltd.
620 Harris St.
Ultimo, N.Sw 2007
Australia,  AU
Applicant Contact KALNIN
Correspondent
Ashai Co. , Ltd.
620 Harris St.
Ultimo, N.Sw 2007
Australia,  AU
Correspondent Contact KALNIN
Regulation Number876.5250
Classification Product Code
KNX  
Date Received06/20/1985
Decision Date 08/27/1985
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
-
-