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Solution, Cold Sterilizing

LFE · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.6885

Classification

FDA Product Code

LFE

Device class

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

Regulation

21 CFR 880.6885

Review panel

DE

Medical specialty

General Hospital

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

Y

Market data

Cleared 510(k) submissions

1

Registered establishments

0

Source

Authoritative

FDA Device Classification database

Machine

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