| 510(k) Number |
K863563 |
| Device Name |
URESIL RADIOPAQUE SILICONE BANDS |
| Applicant |
| Uresil Corp. |
| 5418 W. Touhy Ave. |
|
Skokie,
IL
60077
|
|
| Applicant Contact |
MICHAEL JARON |
| Correspondent |
| Uresil Corp. |
| 5418 W. Touhy Ave. |
|
Skokie,
IL
60077
|
|
| Correspondent Contact |
MICHAEL JARON |
| Date Received | 09/12/1986 |
| Decision Date | 10/02/1986 |
| 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
|
|
|