| Device Classification Name |
General Surgery Tray
|
| 510(k) Number |
K930270 |
| Device Name |
PATIENT PREOPERATIVE PREP TRAY, SINGLE USE |
| Applicant |
| Professional Medical Products, Inc. |
| 1909 NE 25th Ave. |
|
Ocala,
FL
32670
|
|
| Applicant Contact |
LEE CUTRIGHT |
| Correspondent |
| Professional Medical Products, Inc. |
| 1909 NE 25th Ave. |
|
Ocala,
FL
32670
|
|
| Correspondent Contact |
LEE CUTRIGHT |
| Regulation Number | 878.4370 |
| Classification Product Code |
|
| Date Received | 01/19/1993 |
| Decision Date | 02/17/1994 |
| 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
|
|
|