| Device Classification Name |
Tray, Surgical, Instrument
|
| 510(k) Number |
K900376 |
| Device Name |
HAND SURGERY AND IRRIGATION TRAY (MODEL 3625) |
| Applicant |
| Pmt Corp. |
| 1500 Park Rd. |
|
Chanhassen,
MN
55317
|
|
| Applicant Contact |
JOHN DOCKTER |
| Correspondent |
| Pmt Corp. |
| 1500 Park Rd. |
|
Chanhassen,
MN
55317
|
|
| Correspondent Contact |
JOHN DOCKTER |
| Regulation Number | 878.4800 |
| Classification Product Code |
|
| Date Received | 01/26/1990 |
| Decision Date | 04/10/1990 |
| 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
|