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Fetal Pillow is a Single-use,sterile fetal head elevator consisting of a mechanism that elevates the fetal head to facilitate delivery during a Cesarean Section.Fetal Pillow is intended to…
Fetal Head Elevator
Which Manufacturers in China Make This?
One manufacturer in China holds an FDA registration for this device type, based in Jiangsu.
- Clinisupplies (Nanjing) Co., Ltd. Jiangsu, contract manufacturer
What Is This Device?
To elevate the fetal head and facilitate delivery of the fetus in women requiring a Caesarean Section at full dilation or those requiring a Caesarean Section after a failed instrumental vaginal delivery.
What Is FDA Product Code PWB?
Fetal Head Elevator is FDA product code PWB, Class 2, 21 CFR 884.4350.
What Does It Take to Sell It in the United States?
A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.
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