| Device Classification Name |
Endoscopic Grasping/Cutting Instrument, Non-Powered
|
| 510(k) Number |
K943476 |
| Device Name |
GIP/MEDI-GLOBE GOREIGN BODY GRASPERS |
| Applicant |
| Medi-Globe Corp. |
| 6202 S. Maple Ave. # 131 |
|
Tempe,
AZ
85283
|
|
| Applicant Contact |
GINA M GALLEGOS |
| Correspondent |
| Medi-Globe Corp. |
| 6202 S. Maple Ave. # 131 |
|
Tempe,
AZ
85283
|
|
| Correspondent Contact |
GINA M GALLEGOS |
| Regulation Number | 876.1500 |
| Classification Product Code |
|
| Date Received | 07/19/1994 |
| Decision Date | 12/15/1994 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Gastroenterology/Urology
|
| 510k Review Panel |
Gastroenterology/Urology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|