Device, Inflation, Middle Ear
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are based in Guangdong and Zhejiang: 2 hold an FDA registration. 1 is a contract manufacturer.
- Entech Electronics Trade (Shenzhen) Company Ltd. Guangdong, contract manufacturer
- Ningbo Albert Novosino Co., Ltd. Zhejiang, contract manufacturer
How Is MJV Classified?
Device, Inflation, Middle Ear is FDA product code MJV, unclassified.
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. Chinese applicants hold 1 clearance under this code; the FDA took 105 days from receipt to decision.
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