| 510(k) Number |
K852302 |
| Device Name |
INOX IORCEPS JAR |
| Applicant |
| Broadwest Corp. |
| 260 W. Broadway |
|
New York,
NY
10013
|
|
| Applicant Contact |
JACK DONOVAN |
| Correspondent |
| Broadwest Corp. |
| 260 W. Broadway |
|
New York,
NY
10013
|
|
| Correspondent Contact |
JACK DONOVAN |
| Date Received | 05/29/1985 |
| Decision Date | 07/02/1985 |
| 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
|
|
|