MON-A-THERM FOLEY KIT— 510(k) K923538

Clearance details

Applicant

Mallinckrodt Medical

Product code

Code FCM

Device class

Class 2

Regulation

21 CFR 876.5130

Advisory panel

Gastroenterology, Urology

Date received

1992-07-16

Decision date

1993-05-27

Decision

Unknown

Clearance type

Traditional

Location

St Louis, MO, US

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