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 K172197
Device Name SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS
Applicant
Origio A/S
Knardrupvej 2
Måløv,  DK 2760
Applicant Contact Tove Kjaer
Correspondent
Origio A/S
Knardrupvej 2
Måløv,  DK 2760
Correspondent Contact Tove Kjaer
Regulation Number884.6180
Classification Product Code
MQL  
Date Received07/21/2017
Decision Date 10/13/2017
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
Predetermined Change
Control Plan Authorized		 No
-
-