Device Classification Name |
Prosthesis, Breast, External, Used With Adhesive
|
510(k) Number |
K904086 |
Device Name |
DISCRENE SELF-SUPPORTING BREAST FORM |
Applicant |
COLOPLAST A/S |
C/O RICHARD HAMER ASSOC., INC. |
P.O. BOX 16598 |
FT. WORTH,
TX
76162
|
|
Applicant Contact |
RICHARD A HAMER |
Correspondent |
COLOPLAST A/S |
C/O RICHARD HAMER ASSOC., INC. |
P.O. BOX 16598 |
FT. WORTH,
TX
76162
|
|
Correspondent Contact |
RICHARD A HAMER |
Regulation Number | 878.3800
|
Classification Product Code |
|
Date Received | 09/05/1990 |
Decision Date | 10/02/1990 |
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
|