← FDA Medical Device Classifications

Mold, Middle-Ear

ETC · Class II — Moderate Risk (510(k) clearance required) · Ear, Nose, Throat · 21 CFR 874.3430

Classification

FDA Product Code

ETC

Device class

Class II — Moderate Risk (510(k) clearance required)

Regulation

21 CFR 874.3430

Review panel

EN

Medical specialty

Ear, Nose, Throat

Submission type

4

GMP exempt

N

Life sustaining

N

Implant

Y

Third-party review

N

Market data

Cleared 510(k) submissions

1

Registered establishments

4

Source

Authoritative

FDA Device Classification database

Machine

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