| 510(k) Number |
K850595 |
| Device Name |
3 X 4 NON-ADHERENT PAD |
| Applicant |
| American White Cross, Inc. |
| 56 Westcott Rd. |
|
Stamford,
CT
06902
|
|
| Applicant Contact |
CORNELIA DAMSKY |
| Correspondent |
| American White Cross, Inc. |
| 56 Westcott Rd. |
|
Stamford,
CT
06902
|
|
| Correspondent Contact |
CORNELIA DAMSKY |
| Date Received | 02/15/1985 |
| Decision Date | 03/11/1985 |
| 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
|
|
|