| Device Classification Name |
Blade, Scalpel
|
| 510(k) Number |
K844001 |
| Device Name |
LANCE BLADES & SCALPELS |
| Applicant |
| Perry, Div. |
| 1875 Harsh Ave. SE |
| P.O. Box 550 |
|
Massillon,
OH
44648
|
|
| Applicant Contact |
JAMES R CHATTERTON |
| Correspondent |
| Perry, Div. |
| 1875 Harsh Ave. SE |
| P.O. Box 550 |
|
Massillon,
OH
44648
|
|
| Correspondent Contact |
JAMES R CHATTERTON |
| Regulation Number | 878.4800 |
| Classification Product Code |
|
| Date Received | 10/12/1984 |
| Decision Date | 11/08/1984 |
| 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
|
|
|