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Intrauterine Tamponade Balloon

FDA product code OQY · 10 cleared devices

Class 2 Obstetrics/Gynecology
Regulation
21 CFR 884.4530
Review panel
OB
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2010-04-30 – 2026-05-15

provides temporary control or reduction of postpartum uterine bleeding

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