| Device Classification Name |
Razor, Surgical
|
| 510(k) Number |
K910524 |
| Device Name |
SURGICAL CLIPPER |
| Applicant |
| Baxter Healthcare Corp |
| 27200 N. Tourney Rd. |
| P.O. Box 5900 |
|
Valencia,
CA
91355 -8900
|
|
| Applicant Contact |
STEPHEN A CAMPBELL |
| Correspondent |
| Baxter Healthcare Corp |
| 27200 N. Tourney Rd. |
| P.O. Box 5900 |
|
Valencia,
CA
91355 -8900
|
|
| Correspondent Contact |
STEPHEN A CAMPBELL |
| Regulation Number | 878.4800 |
| Classification Product Code |
|
| Date Received | 02/07/1991 |
| Decision Date | 03/28/1991 |
| 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
|
|
|