NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS— 510(k) K130512

Clearance details

Applicant

Heinz Kurz GmbH Medizintechnik

Product code

Code ETB

Device class

Class 2

Regulation

21 CFR 874.3450

Advisory panel

Ear, Nose, Throat

Date received

2013-02-27

Decision date

2013-12-02

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Dusslingen, DE

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