Device Classification Name |
prosthesis, breast, external, used with adhesive
|
510(k) Number |
K921535 |
Device Name |
SUOENA AFFINITY (TM) MODEL #802 |
Applicant |
COLOPLAST CORP. |
2150 NEW MARKET PARKWAY, |
SUITE 116 |
MARIETTA,
GA
30067
|
|
Applicant Contact |
LEE LEWIS |
Correspondent |
COLOPLAST CORP. |
2150 NEW MARKET PARKWAY, |
SUITE 116 |
MARIETTA,
GA
30067
|
|
Correspondent Contact |
LEE LEWIS |
Regulation Number | 878.3800
|
Classification Product Code |
|
Date Received | 03/31/1992 |
Decision Date | 05/11/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|