KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170


definition

Device Classification Name

prosthesis, partial ossicular replacement

510(k) Number K002221
Device Name KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170
Original Applicant
HEINZ KURZ GMBH MEDIZINTECHNIK
amstel 320-i
amsterdam, 

NL

1017 ap

Original Contact dagmar s maser
Regulation Number 874.3450
Classification Product Code
ETB  
Date Received 07/24/2000
Decision Date 08/09/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

Type Traditional
Reviewed by Third Party No

Combination Product

No