| Device Classification Name |
insufflator, laparoscopic
|
|---|
| 510(K) Number |
K122180 |
|---|
| Model |
UHI-4
|
| Device Name |
HIGH FLOW INSUFFLANTION UNIT |
|---|
| Applicant |
| OLYMPUS MEDICAL SYSTEMS CORPORATION |
| 3500 corporate parkway |
| po box 610 |
|
center valley,
PA
18034 0610
|
|
| Contact |
daphney germain-kolawole |
| Regulation Number | 884.1730
|
|---|
| Classification Product Code |
|
|---|
| Subsequent Product Codes |
|
|---|
| Date Received | 07/23/2012 |
|---|
| Decision Date | 11/13/2012 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Obstetrics/Gynecology
|
|---|
| Review Advisory Committee |
Gastroenterology/Urology
|
|---|
| summary |
summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
