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 Catheter, Retention Type, Balloon
510(k) Number K961697
Device Name OPTICON FEMALE URINARY INCONTINENCE CATHETER FOR CONTINUOUS DRAINAGE
Applicant
MEDICAL DEVICE INTL., INC.
5116 BIRCH RD.
MINNETONKA,  MN  55345
Applicant Contact GREG SACHS
Correspondent
MEDICAL DEVICE INTL., INC.
5116 BIRCH RD.
MINNETONKA,  MN  55345
Correspondent Contact GREG SACHS
Regulation Number876.5130
Classification Product Code
EZL  
Date Received05/02/1996
Decision Date 08/30/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-