NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS


Device Classification Name

prosthesis, partial ossicular replacement

510(k) Number K112616
Device Name NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS
Applicant
HEINZ KURZ GMBH MEDIZINTECHNIK
amstel 320-1
amsterdam, 

NL

1017 ap

Applicant Contact kristina bitzer
Correspondent
HEINZ KURZ GMBH MEDIZINTECHNIK
amstel 320-1
amsterdam, 

NL

1017 ap

Correspodent Contact kristina bitzer
Regulation Number 874.3450
Classification Product Code
ETB  
Date Received 09/08/2011
Decision Date 02/08/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No