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FDA 510(k), K223098, Bakri Essential Postpartum Balloon
FDA 510(k), K223098, Bakri Essential Postpartum Balloon
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$149.00 USD
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510(K) Number: K223098
Device Name: Bakri Essential Postpartum Balloon
Manufacturer: Ian Herman
Device Classification Name: Intrauterine Tamponade Balloon
Regulation Number: OQY
Classification Product Code: 09/30/2022
Date Received: 10/28/2022
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: Bakri Essential Postpartum Balloon
Manufacturer: Ian Herman
Device Classification Name: Intrauterine Tamponade Balloon
Regulation Number: OQY
Classification Product Code: 09/30/2022
Date Received: 10/28/2022
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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