| Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
|---|
| 510(k) Number |
K001438 |
|---|
| Device Name |
SOMNUS MODEL S2 ELECTROSURGICAL GENERATOR |
|---|
| Applicant |
| SOMNUS MEDICAL TECHNOLOGIES, INC. |
| 285 NORTH WOLFE RD. |
|
SUNNYVALE,
CA
94086
|
|
| Applicant Contact |
STEVEN J OJALA, PH.D |
| Correspondent |
| SOMNUS MEDICAL TECHNOLOGIES, INC. |
| 285 NORTH WOLFE RD. |
|
SUNNYVALE,
CA
94086
|
|
| Correspondent Contact |
STEVEN J OJALA, PH.D |
| Regulation Number | 878.4400
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 05/08/2000 |
|---|
| Decision Date | 05/16/2000 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
General & Plastic Surgery
|
|---|
| 510k Review Panel |
General & Plastic Surgery
|
|---|
| Type |
Special
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|