| Device Classification Name |
Laparoscope, General & Plastic Surgery
|
| 510(k) Number |
K940199 |
| Device Name |
DISSECTOR |
| Applicant |
| Automated Medical Products Corp. |
| 646 E. Apple Tree Dr. |
|
Sandy,
UT
84070
|
|
| Applicant Contact |
DREW D WEAVER |
| Correspondent |
| Automated Medical Products Corp. |
| 646 E. Apple Tree Dr. |
|
Sandy,
UT
84070
|
|
| Correspondent Contact |
DREW D WEAVER |
| Regulation Number | 876.1500 |
| Classification Product Code |
|
| Date Received | 01/13/1994 |
| Decision Date | 03/30/1994 |
| 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
|
|
|