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 urinary drainage collection kit, for indwelling catheter
510(k) Number K890096
Device Name BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAG
Applicant
MEDICAL INVENTORS CORP., INC.
7575 DR. PHILLIPS BLVD.,
SUITE #310
ORLANDO,  FL  32819
Applicant Contact ROLAND C ZAGNOLI
Correspondent
MEDICAL INVENTORS CORP., INC.
7575 DR. PHILLIPS BLVD.,
SUITE #310
ORLANDO,  FL  32819
Correspondent Contact ROLAND C ZAGNOLI
Regulation Number876.5250
Classification Product Code
FCN  
Date Received01/10/1989
Decision Date 07/14/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-