Device Classification Name |
Tape And Bandage, Adhesive
|
510(k) Number |
K843875 |
Device Name |
LEUKOSILK |
Applicant |
BEIERSDORF, INC. |
P.O. BOX 5529 |
NORWALK ,
CT
06856 -
|
|
Applicant Contact |
JOHN R TREMBLEY |
Correspondent |
BEIERSDORF, INC. |
P.O. BOX 5529 |
NORWALK ,
CT
06856 -
|
|
Correspondent Contact |
JOHN R TREMBLEY |
Regulation Number | 880.5240
|
Classification Product Code |
|
Date Received | 10/02/1984 |
Decision Date | 02/21/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|