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 K971271
Device Name BESECURE EXTERNAL URINARY COLLECTION SYSTEM
Applicant
Urology Research Intl., Inc.
P.O. Box 02544
Cleveland,  OH  44102
Applicant Contact FRANK A MANFREDI
Correspondent
Urology Research Intl., Inc.
P.O. Box 02544
Cleveland,  OH  44102
Correspondent Contact FRANK A MANFREDI
Regulation Number876.5250
Classification Product Code
KNX  
Date Received04/04/1997
Decision Date 08/18/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-