Device Classification Name |
polymer, ent synthetic-polyamide (mesh or foil material)
|
510(k) Number |
K043035 |
Device Name |
SEPRAGEL ENT BIORESORBABLE PACKING/STENT |
Applicant |
GENZYME CORPORATION |
55 CAMBRIDGE PARKWAY |
CAMBRIDGE,
MA
02142
|
|
Applicant Contact |
BARBARA PIZZA |
Correspondent |
GENZYME CORPORATION |
55 CAMBRIDGE PARKWAY |
CAMBRIDGE,
MA
02142
|
|
Correspondent Contact |
BARBARA PIZZA |
Regulation Number | 874.3620
|
Classification Product Code |
|
Date Received | 11/03/2004 |
Decision Date | 07/11/2005 |
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
|
|
|