| Device Classification Name |
Clip, Removable (Skin)
|
| 510(k) Number |
K873744 |
| Device Name |
LEUKOCLIP(R) |
| 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 | 878.4320 |
| Classification Product Code |
|
| Date Received | 09/16/1987 |
| Decision Date | 09/30/1987 |
| 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
|
Predetermined Change Control Plan Authorized |
No
|
|
|