Jada System

Intrauterine Tamponade Balloon

Alydia Health

The following data is part of a premarket notification filed by Alydia Health with the FDA for Jada System.

Pre-market Notification Details

Device IDK201199
510k NumberK201199
Device Name:Jada System
ClassificationIntrauterine Tamponade Balloon
Applicant Alydia Health 3495 Edison Way Menlo Park,  CA  94025
ContactColby Holtshouse
CorrespondentCindy Domecus
Domecus Consulting Services LLC 1171 Barroilhet Drive Hillsborough,  CA  94010
Product CodeOQY  
CFR Regulation Number884.4530 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-04
Decision Date2020-08-28

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