| 510(k) Number |
K863777 |
| Device Name |
B-WRAP |
| Applicant |
| Bdf Plaza |
| Bdf Plz. |
| P.O. Box 5529 |
|
Norwalk,
CT
06856
|
|
| Applicant Contact |
VINCENT MILANO |
| Correspondent |
| Bdf Plaza |
| Bdf Plz. |
| P.O. Box 5529 |
|
Norwalk,
CT
06856
|
|
| Correspondent Contact |
VINCENT MILANO |
| Date Received | 09/26/1986 |
| Decision Date | 10/24/1986 |
| 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
|
|
|