| Device Classification Name |
Dressing, Wound And Burn, Occlusive
|
| 510(k) Number |
K943363 |
| Device Name |
CUTIPLAST STERIL |
| Applicant |
| Beiersdorf, Inc. |
| 360 Dr. Martin Luther King Dr. |
| P.O. Box 5529 |
|
Norwalk,
CT
06856
|
|
| Applicant Contact |
ELIZABETH H ANDERSON |
| Correspondent |
| Beiersdorf, Inc. |
| 360 Dr. Martin Luther King Dr. |
| P.O. Box 5529 |
|
Norwalk,
CT
06856
|
|
| Correspondent Contact |
ELIZABETH H ANDERSON |
| Classification Product Code |
|
| Date Received | 07/13/1994 |
| Decision Date | 03/15/1995 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|