Bakri Essential Postpartum Balloon

Intrauterine Tamponade Balloon

Cook Incorporated

The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Bakri Essential Postpartum Balloon.

Pre-market Notification Details

Device IDK223098
510k NumberK223098
Device Name:Bakri Essential Postpartum Balloon
ClassificationIntrauterine Tamponade Balloon
Applicant Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington,  IN  47402
ContactIan Herman
CorrespondentIan Herman
Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington,  IN  47402
Product CodeOQY  
CFR Regulation Number884.4530 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-09-30
Decision Date2022-10-28

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