CLIP PISTON AWENGEN, MODEL# 1006 805 – 1006 861


Device Classification Name

prosthesis, partial ossicular replacement

510(k) Number K021479
Device Name CLIP PISTON AWENGEN, MODEL# 1006 805 – 1006 861
Original Applicant
HEINZ KURZ GMBH MEDIZINTECHNIK
amstel 320-i
amsterdam, 

NL

1017 ap

Original Contact dagmar maser
Regulation Number 874.3450
Classification Product Code
ETB  
Date Received 05/08/2002
Decision Date 05/21/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No