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 Intrauterine Tamponade Balloon
510(k) Number K191264
Device Name Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)
Applicant
Ujenzi Charitable Trust
22 Welgate Road
Medford,  MA  02155
Applicant Contact Thomas Burke
Correspondent
Hogan Lovells US LLP
555 13th St. NW
Washington,  DC  20004
Correspondent Contact Jonathan S. Kahan
Regulation Number884.4530
Classification Product Code
OQY  
Date Received05/10/2019
Decision Date 10/30/2019
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
-
-