| Device Classification Name |
System, Suction, Lipoplasty For Removal
|
|---|
| 510(k) Number |
K010311 |
|---|
| Device Name |
LIPOMATIC; LIPOMATIC LIPOSUCTION DEVICE |
|---|
| Applicant |
| Euromi S.A |
| P.O. Box 2156 |
|
Huntington,
CT
06484
|
|
| Applicant Contact |
JOSEPH M AZARY |
| Correspondent |
| Euromi S.A |
| P.O. Box 2156 |
|
Huntington,
CT
06484
|
|
| Correspondent Contact |
JOSEPH M AZARY |
| Regulation Number | 878.5040 |
|---|
| Classification Product Code |
|
|---|
| Date Received | 02/01/2001 |
|---|
| Decision Date | 06/29/2001 |
|---|
| 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
|
|---|