| Device Classification Name |
System, Suction, Lipoplasty For Removal
|
| 510(k) Number |
K081593 |
| Device Name |
POWER ASPIRATOR, MODEL LS2 OR LS2DP |
| Applicant |
| Medical Device Resource Corp. |
| 23392 Connecticut St. |
|
Hayward,
CA
94545
|
|
| Applicant Contact |
MEL KIMSEY |
| Correspondent |
| Medical Device Resource Corp. |
| 23392 Connecticut St. |
|
Hayward,
CA
94545
|
|
| Correspondent Contact |
MEL KIMSEY |
| Regulation Number | 878.5040 |
| Classification Product Code |
|
| Date Received | 06/06/2008 |
| Decision Date | 07/23/2008 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General & Plastic Surgery
|
| 510k Review Panel |
General & Plastic Surgery
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|