| Device Classification Name |
laparoscope, general & plastic surgery
|
|---|
| 510(K) Number |
K121701 |
|---|
| Model |
ENDOALPHA (MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-3) SOFTWARE VERSION 4
|
| Device Name |
SYSTEMS INTEGRATION |
|---|
| Applicant |
| OLYMPUS MEDICAL SYSTEMS CORP. |
| 3500 corporate parkway |
| p.o. box 610 |
|
center valley,
PA
18034 0610
|
|
| Contact |
kathy anderson |
| Regulation Number | 876.1500
|
|---|
| Classification Product Code |
|
|---|
| Subsequent Product Code |
|
|---|
| Date Received | 06/08/2012 |
|---|
| Decision Date | 06/29/2012 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
General & Plastic Surgery
|
|---|
| Review Advisory Committee |
Gastroenterology/Urology
|
|---|
| Type |
Special
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
