Device Classification Name |
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
|
510(k) Number |
K070093 |
Device Name |
OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTE |
Applicant |
CEREMED INC. |
3643 LENAWEE AVE. |
LOS ANGELES,
CA
90016
|
|
Applicant Contact |
TADEUSZ WELLISZ M.D. |
Correspondent |
CEREMED INC. |
3643 LENAWEE AVE. |
LOS ANGELES,
CA
90016
|
|
Correspondent Contact |
TADEUSZ WELLISZ M.D. |
Regulation Number | 874.3620
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/10/2007 |
Decision Date | 01/24/2007 |
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
|
|
|