← FDA Medical Device Classifications

Depressor, Tongue, Non-Surgical

FMA · Class I — Low Risk (general controls) · General Hospital · 21 CFR 880.6230

Classification

FDA Product Code
FMA
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 880.6230
Review panel
HO
Medical specialty
General Hospital
Submission type
4
GMP exempt
Y
Life sustaining
N
Implant
N
Third-party review
N

Market data

Cleared 510(k) submissions
5
Registered establishments
210

Source

Authoritative
FDA Device Classification database
Machine
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