| Device Classification Name |
Scissors, General, Surgical
|
| 510(k) Number |
K911158 |
| Device Name |
MICRO SCISSORS, 5MM CURVE MICRO SCISSORS, 5MM |
| Applicant |
| Northgate Technologies, Inc. |
| 3930 Ventura Dr. |
|
Arlington Heights,
IL
60004
|
|
| Applicant Contact |
SAMUELLA D EMRICH |
| Correspondent |
| Northgate Technologies, Inc. |
| 3930 Ventura Dr. |
|
Arlington Heights,
IL
60004
|
|
| Correspondent Contact |
SAMUELLA D EMRICH |
| Regulation Number | 878.4800 |
| Classification Product Code |
|
| Date Received | 03/15/1991 |
| Decision Date | 03/29/1991 |
| 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
|
|
|