| Device Classification Name |
Laparoscope, General & Plastic Surgery
|
| 510(k) Number |
K924728 |
| Device Name |
KNOT PUSHER |
| Applicant |
| Advanced Surgical, Inc. |
| 305 College Rd. E. |
|
Princeton,
NJ
08540
|
|
| Applicant Contact |
HARRIET SCHWARTZMAN |
| Correspondent |
| Advanced Surgical, Inc. |
| 305 College Rd. E. |
|
Princeton,
NJ
08540
|
|
| Correspondent Contact |
HARRIET SCHWARTZMAN |
| Regulation Number | 876.1500 |
| Classification Product Code |
|
| Date Received | 09/21/1992 |
| Decision Date | 12/29/1992 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Gastroenterology/Urology
|
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|