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 K150950
Device Name FreezeKit Cleave , ThawKit Cleave
Applicant
VITROLIFE SWEDEN AB
3601 SOUTH INCA STREET
ENGLEWOOD,  CO  80110
Applicant Contact Brett Sonet Glazar
Correspondent
VITROLIFE SWEDEN AB
3601 SOUTH INCA STREET
ENGLEWOOD,  CO  80110
Correspondent Contact Brett Sonet Glazar
Regulation Number884.6180
Classification Product Code
MQL  
Date Received04/08/2015
Decision Date 12/21/2015
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
-
-