Device Classification Name |
Bandage, Liquid
|
510(k) Number |
K944581 |
Device Name |
CUTINOVA THIN WOUND DRESSING |
Applicant |
BEIERSDORF, INC. |
360 DR. MARTIN LUTHER KING DR. |
P.O. BOX 5529 |
NORWALK,
CT
06856 -5529
|
|
Applicant Contact |
KENNETH M NICOLL |
Correspondent |
BEIERSDORF, INC. |
360 DR. MARTIN LUTHER KING DR. |
P.O. BOX 5529 |
NORWALK,
CT
06856 -5529
|
|
Correspondent Contact |
KENNETH M NICOLL |
Regulation Number | 880.5090
|
Classification Product Code |
|
Date Received | 09/19/1994 |
Decision Date | 12/02/1994 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|