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1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Rasp, Ear

Device class

Class I (low risk)

Regulation

21 CFR 874.4420

Medical specialty

Ear, Nose, Throat

Adverse events (MAUDE)

1997: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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