TAMPONADE UTERINE BALLOON CATHETER SET— 510(k) K013597

Clearance details

Applicant

Cook Ob/Gyn

Product code

Code KNA

Device class

Class 2

Regulation

21 CFR 884.4530

Advisory panel

Obstetrics/Gynecology

Date received

2001-10-31

Decision date

2002-04-17

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Spencer, IN, US

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