| Device Classification Name |
Spatula, Surgical, General & Plastic Surgery
|
| 510(k) Number |
K882793 |
| Device Name |
PMT FUKUSHIMA MICROSURGICAL INSTRUMENT LINE |
| Applicant |
| Pmt Corp. |
| 1500 Park Rd. |
|
Chanhassen,
MN
55317
|
|
| Applicant Contact |
ALFRED A IVERSEN |
| Correspondent |
| Pmt Corp. |
| 1500 Park Rd. |
|
Chanhassen,
MN
55317
|
|
| Correspondent Contact |
ALFRED A IVERSEN |
| Regulation Number | 878.4800 |
| Classification Product Code |
|
| Date Received | 07/06/1988 |
| Decision Date | 07/18/1988 |
| 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
|