Saw, Surgical, Ent (Electric or Pneumatic)
Which Manufacturers in China Make This?
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 EWQ Classified?
Saw, Surgical, Ent (Electric Or Pneumatic) is FDA product code EWQ, 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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