| Device Classification Name |
Apparatus, Exhaust, Surgical
|
| 510(k) Number |
K020510 |
| Device Name |
SMOKE EVACUATION HOSES/TUBING |
| Applicant |
| Dm Medical, Inc. |
| 10865 Millington Ct. |
|
Cincinnati,
OH
45242
|
|
| Applicant Contact |
ROBERT W MAYS |
| Correspondent |
| Dm Medical, Inc. |
| 10865 Millington Ct. |
|
Cincinnati,
OH
45242
|
|
| Correspondent Contact |
ROBERT W MAYS |
| Regulation Number | 878.5070 |
| Classification Product Code |
|
| Date Received | 02/15/2002 |
| Decision Date | 05/03/2002 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General & Plastic Surgery
|
| 510k Review Panel |
General Hospital
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|