| 510(k) Number |
K864923 |
| Device Name |
VACU-PREP |
| Applicant |
| Diversified High Tech Co. |
| Kleinfeld, Kaplan & Becker |
| 1140 Nineteenth St., NW |
|
Washington,
DC
20036
|
|
| Applicant Contact |
PETER O SAFIR |
| Correspondent |
| Diversified High Tech Co. |
| Kleinfeld, Kaplan & Becker |
| 1140 Nineteenth St., NW |
|
Washington,
DC
20036
|
|
| Correspondent Contact |
PETER O SAFIR |
| Date Received | 12/16/1986 |
| Decision Date | 01/20/1987 |
| 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
|
|
|