| Device Classification Name |
hysteroscope (and accessories)
|
|---|
| 510(K) Number |
K122498 |
|---|
| Models |
50-401,
50-403
|
| Device Name |
MYOSURE XL TISSUE REMOVAL DEVICE (1 PACK) MYOSURE XL TISSUE REMOVAL DEVICE (3 PACK) |
|---|
| Applicant |
| HOLOGIC, INC. |
| 250 campus drive |
|
marlborough,
MA
01752
|
|
| Contact |
sarah fairfield |
| Regulation Number | 884.1690
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 08/16/2012 |
|---|
| Decision Date | 09/10/2012 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Obstetrics/Gynecology
|
|---|
| Review Advisory Committee |
Obstetrics/Gynecology
|
|---|
| summary |
summary
|
| Type |
Special
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
