TITANIUM VOCAL FOLD MEDIALIZING IMPLANT, MODELS 5001 001 (FEMALE), AND 5001 003 (MALE)


Device Classification Name

polymer, ent synthetic-polyamide (mesh or foil material)

510(k) Number K991324
Device Name TITANIUM VOCAL FOLD MEDIALIZING IMPLANT, MODELS 5001 001 (FEMALE), AND 5001 003 (MALE)
Applicant
HEINZ KURZ
tuebinger strasse 3
dusslingen, 

DE

d-72144

Applicant Contact dagmar s maser
Correspondent
HEINZ KURZ
tuebinger strasse 3
dusslingen, 

DE

d-72144

Correspodent Contact dagmar s maser
Regulation Number 874.3620
Classification Product Code
KHJ  
Date Received 04/19/1999
Decision Date 05/18/1999
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