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 K820565
Device Name MALE EXTERNAL CATHETER
Applicant
UROCARE PRODUCTS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
UROCARE PRODUCTS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.5250
Classification Product Code
KNX  
Date Received03/02/1982
Decision Date 04/01/1982
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
-
-