Device Classification Name |
beads, hydrophilic, for wound exudate absorption
|
510(k) Number |
K905688 |
Device Name |
CUTINOVA HYDRO |
Applicant |
BEIERSDORF, INC. |
360 MARTIN LUTHER KING DR. |
P.O. BOX 5529 |
NORWALK,
CT
06856
|
|
Applicant Contact |
VINCENT MILANO |
Correspondent |
BEIERSDORF, INC. |
360 MARTIN LUTHER KING DR. |
P.O. BOX 5529 |
NORWALK,
CT
06856
|
|
Correspondent Contact |
VINCENT MILANO |
Regulation Number | 878.4018
|
Classification Product Code |
|
Date Received | 12/19/1990 |
Decision Date | 04/01/1991 |
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
|
|
|