← FDA Medical Device Classifications

Set, Dialysis, Single Needle (Co-Axial Flow)

LBW · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.5540

Classification

FDA Product Code

LBW

Device class

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

Regulation

21 CFR 876.5540

Review panel

GU

Medical specialty

Gastroenterology, Urology

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

Y

Third-party review

N

Market data

Cleared 510(k) submissions

5

Registered establishments

0

Source

Authoritative

FDA Device Classification database

Machine

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