Device Classification Name |
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
|
510(k) Number |
K982870 |
Device Name |
EPIFILM OTOLOGIC LAMINA |
Applicant |
XOMED, INC. |
6743 SOUTHPOINT DR. NORTH |
JACKSONVILLE,
FL
32216 -0980
|
|
Applicant Contact |
ROY BERENS |
Correspondent |
XOMED, INC. |
6743 SOUTHPOINT DR. NORTH |
JACKSONVILLE,
FL
32216 -0980
|
|
Correspondent Contact |
ROY BERENS |
Regulation Number | 874.3620
|
Classification Product Code |
|
Date Received | 08/14/1998 |
Decision Date | 11/03/1998 |
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
|
|
|