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, Assisted Reproduction
510(k) Number K120154
Device Name INTRAUTERINE INSEMINATION (IUI) CATHETER
Applicant
Catheter Research, Inc.
5610 W. 82nd St.
Indianapolis,  IN  46278
Applicant Contact BABACAR DIOUF
Correspondent
Catheter Research, Inc.
5610 W. 82nd St.
Indianapolis,  IN  46278
Correspondent Contact BABACAR DIOUF
Regulation Number884.6110
Classification Product Code
MQF  
Date Received01/18/2012
Decision Date 03/21/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-