Insufflator, Vaginal
Which Manufacturers in China Make This?
One manufacturer in China holds an FDA registration for this device type, based in Shandong.
- Shandong Zhushi Pharmaceutical Group Co., Ltd. Shandong, contract manufacturer
How Is HEC Classified?
Insufflator, Vaginal is FDA product code HEC, Class 1, 21 CFR 884.5920.
What Does It Take to Sell It in the United States?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.
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