← FDA Medical Device Classifications

Elastomer, Silicone, For Scar Management

MDA · Class I — Low Risk (general controls) · General, Plastic Surgery · 21 CFR 878.4025

Classification

FDA Product Code

MDA

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 878.4025

Review panel

SU

Medical specialty

General, Plastic Surgery

Submission type

4

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

81

Registered establishments

181

Source

Authoritative

FDA Device Classification database

Machine

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