Device Classification Name |
Elastomer, Silicone Block
|
510(k) Number |
K974482 |
Device Name |
SILIMED GLUTEAL IMPLANT |
Applicant |
SILIMED, LLC. |
P.O BOX 4341 |
CROFTON,
MD
21114
|
|
Applicant Contact |
E J SMITH |
Correspondent |
SILIMED, LLC. |
P.O BOX 4341 |
CROFTON,
MD
21114
|
|
Correspondent Contact |
E J SMITH |
Regulation Number | 874.3620
|
Classification Product Code |
|
Date Received | 11/26/1997 |
Decision Date | 02/24/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|