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 media, reproductive
510(k) Number K043116
Device Name ICSI-100
Applicant
VITROLIFE SWEDEN AB
FAKTORVAGEN 13
KUNGSBACKA,  SE SE-434 37
Applicant Contact MORGAN HUGOSSON
Correspondent
VITROLIFE SWEDEN AB
FAKTORVAGEN 13
KUNGSBACKA,  SE SE-434 37
Correspondent Contact MORGAN HUGOSSON
Regulation Number884.6180
Classification Product Code
MQL  
Date Received11/10/2004
Decision Date 01/13/2005
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 Yes
-
-