| Device Classification Name |
Instrument, Biopsy
|
|---|
| 510(k) Number |
K012023 |
|---|
| Device Name |
ANCHOR GUIDE LESION LOCALIZATION DEVICE; ANCOR GUIDE HOLDER; RF GENERATOR CABLE |
|---|
| Applicant |
| Senorx, Inc. |
| 11 Columbia, Suite A |
|
Aliso Viejo,
CA
92656
|
|
| Applicant Contact |
AMY BOUCLY |
| Correspondent |
| Senorx, Inc. |
| 11 Columbia, Suite A |
|
Aliso Viejo,
CA
92656
|
|
| Correspondent Contact |
AMY BOUCLY |
| Regulation Number | 876.1075 |
|---|
| Classification Product Code |
|
|---|
| Date Received | 06/28/2001 |
|---|
| Decision Date | 09/12/2001 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Gastroenterology/Urology
|
|---|
| 510k Review Panel |
Gastroenterology/Urology
|
|---|
| Summary |
Summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|