ComASP Cefiderocol 0.008-128— 510(k) K230479

Clearance details

Applicant

Liofilchem s.r.l.

Product code

Code JWY

Device class

Class 2

Regulation

21 CFR 866.1640

Advisory panel

Microbiology

Date received

2023-02-22

Decision date

2023-05-18

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Roseto Degli Abruzzi, IT

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