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FJO · Class I — Low Risk (general controls) · Gastroenterology, Urology · 21 CFR 876.5540

Classification

FDA Product Code

FJO

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 876.5540

Review panel

GU

Medical specialty

Gastroenterology, Urology

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

Y

Market data

Cleared 510(k) submissions

0

Registered establishments

0

Source

Authoritative

FDA Device Classification database

Machine

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