NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS— 510(k) K112616

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

2011-09-08

Decision date

2013-02-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Amsterdam, NL

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