Device Classification Name |
prosthesis, breast, external, used with adhesive
|
510(k) Number |
K932978 |
Device Name |
CALSSIQUE OR MYSTIQUE |
Applicant |
DEKUMED, KUNSTSTOFFTECHNIK DEGLER GMBH |
AM ANGER 27 |
8214 BERNAU |
GERMANY,
DE
|
|
Applicant Contact |
PETER RICKAUER |
Correspondent |
DEKUMED, KUNSTSTOFFTECHNIK DEGLER GMBH |
AM ANGER 27 |
8214 BERNAU |
GERMANY,
DE
|
|
Correspondent Contact |
PETER RICKAUER |
Regulation Number | 878.3800
|
Classification Product Code |
|
Date Received | 06/17/1993 |
Decision Date | 12/22/1993 |
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
|
|
|