← FDA Medical Device Classifications

Depressor, Metal Tongue, Surgical

KBL · Class I — Low Risk (general controls) · Ear, Nose, Throat · 21 CFR 874.4420

Classification

FDA Product Code

KBL

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 874.4420

Review panel

EN

Medical specialty

Ear, Nose, Throat

Submission type

4

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

1

Registered establishments

114

Source

Authoritative

FDA Device Classification database

Machine

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