Gauge, Mastoid
Who Makes This Device Type in China?
One manufacturer in China holds an FDA registration for this device type, based in Shanghai.
- Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai, contract manufacturer
How Is JYI Classified?
Gauge, Mastoid is FDA product code JYI, Class 1, 21 CFR 874.4420.
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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