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 cannula, manipulator/injector, uterine
510(k) Number K083690
Device Name FEMVUE(TM) CATHETER SYSTEM
Applicant
FEMASYS INC.
5000 RESEARCH COURT STE .100
SUWANEE,  GA  30024
Applicant Contact MARC FINCH
Correspondent
FEMASYS INC.
5000 RESEARCH COURT STE .100
SUWANEE,  GA  30024
Correspondent Contact MARC FINCH
Regulation Number884.4530
Classification Product Code
LKF  
Date Received12/12/2008
Decision Date 06/23/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-