| Device Classification Name |
Laparoscope, General & Plastic Surgery
|
| 510(k) Number |
K926335 |
| Device Name |
IDEAS PEANUT WAND |
| Applicant |
| Ideal Medical, Inc. |
| 12167 49th St. N. |
| P.O. Box 17327 |
|
Clearwater,
FL
34622
|
|
| Applicant Contact |
LORNA K LINVILLE |
| Correspondent |
| Ideal Medical, Inc. |
| 12167 49th St. N. |
| P.O. Box 17327 |
|
Clearwater,
FL
34622
|
|
| Correspondent Contact |
LORNA K LINVILLE |
| Regulation Number | 876.1500 |
| Classification Product Code |
|
| Date Received | 12/16/1992 |
| Decision Date | 06/24/1993 |
| 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
|
|
|