• 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 K201199
Device Name Jada System
Alydia Health
3495 Edison Way
Menlo Park,  CA  94025
Applicant Contact Colby Holtshouse
Domecus Consulting Services LLC
1171 Barroilhet Drive
Hillsborough,  CA  94010
Correspondent Contact Cindy Domecus
Regulation Number884.4530
Classification Product Code
Date Received05/04/2020
Decision Date 08/28/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Clinical Trials NCT02883673
Reviewed by Third Party No
Combination Product No