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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name intrauterine tamponade balloon
510(k) Number K212757
Device Name Jada System
Applicant
Alydia Health
3495 Edison Way
Menlo Park,  CA  94025
Applicant Contact Colby Holtshouse
Correspondent
Domecus Consulting Services LLC
1171 Barroilhet Drive
Hillsborough,  CA  94010
Correspondent Contact Cindy Domecus
Regulation Number884.4530
Classification Product Code
OQY  
Date Received08/31/2021
Decision Date 09/30/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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