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HME · Class I — Low Risk (general controls) · Ophthalmic · 21 CFR 886.1140

Classification

FDA Product Code

HME

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 886.1140

Review panel

OP

Medical specialty

Ophthalmic

Submission type

4

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

16

Registered establishments

33

Source

Authoritative

FDA Device Classification database

Machine

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