Device Classification Name |
Prosthesis, Breast, External, Used With Adhesive
|
510(k) Number |
K904316 |
Device Name |
NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHT |
Applicant |
COLOPLAST CORP. |
2150 NEW MARKET PARKWAY, |
SUITE 116 |
MARIETTA,
GA
30067
|
|
Applicant Contact |
TRACY L SADOWSKI |
Correspondent |
COLOPLAST CORP. |
2150 NEW MARKET PARKWAY, |
SUITE 116 |
MARIETTA,
GA
30067
|
|
Correspondent Contact |
TRACY L SADOWSKI |
Regulation Number | 878.3800
|
Classification Product Code |
|
Date Received | 09/21/1990 |
Decision Date | 10/11/1990 |
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
|
|
|