| 510(k) Number |
K863557 |
| Device Name |
BLADE, SURGICAL PREPARATION RAZOR, STRAIGHT,SINGLE |
| Applicant |
| American Safety Razor Co. |
| P.O. Box 500 |
|
Staunton,
VA
24401
|
|
| Applicant Contact |
EMERSON L DEITZ |
| Correspondent |
| American Safety Razor Co. |
| P.O. Box 500 |
|
Staunton,
VA
24401
|
|
| Correspondent Contact |
EMERSON L DEITZ |
| Date Received | 09/12/1986 |
| Decision Date | 10/06/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|