| Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
|---|
| 510(k) Number |
K080557 |
|---|
| Device Name |
BARRX MODELS HALO360 AND HALO360+ COAGULATION CATHETERS |
|---|
| Applicant |
| BARRX MEDICAL, INCORPORATED |
| 540 OAKMEAD PARKWAY |
|
SUNNYVALE,
CA
94085
|
|
| Applicant Contact |
VIORICA FILIMON |
| Correspondent |
| BARRX MEDICAL, INCORPORATED |
| 540 OAKMEAD PARKWAY |
|
SUNNYVALE,
CA
94085
|
|
| Correspondent Contact |
VIORICA FILIMON |
| Regulation Number | 878.4400
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 02/28/2008 |
|---|
| Decision Date | 04/02/2008 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
General & Plastic Surgery
|
|---|
| 510k Review Panel |
General & Plastic Surgery
|
|---|
| Summary |
Summary
|
| Type |
Special
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|