| Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
| 510(k) Number |
K925830 |
| Device Name |
MICROSURGE SUCTION/IRRIGATION SYSTEM |
| Applicant |
| Microsurge, Inc. |
| 45 W. St. |
| Suite 2 |
|
North Attleboro,
MA
02703
|
|
| Applicant Contact |
MARY M MCNAMARA |
| Correspondent |
| Microsurge, Inc. |
| 45 W. St. |
| Suite 2 |
|
North Attleboro,
MA
02703
|
|
| Correspondent Contact |
MARY M MCNAMARA |
| Regulation Number | 878.4400 |
| Classification Product Code |
|
| Date Received | 11/17/1992 |
| Decision Date | 05/17/1993 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General & Plastic Surgery
|
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|