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
|
|
Correspondent Contact |
DAGMAR S MASER |
Regulation Number | 874.3620
|
Classification Product Code |
|
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
|
|
|