| Device Classification Name |
arthroscope
|
|---|
| 510(K) Number |
K122861 |
|---|
| Model |
XT-15-5, XT-15-6, XT-4-5, XT-40-6
|
| Device Name |
XTOOL |
|---|
| Applicant |
| OUROBOROS MEDICAL |
| 47757 fremont blvd |
|
fremont,
CA
94538
|
|
| Contact |
shelley trimm |
| Regulation Number | 888.1100
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 09/26/2012 |
|---|
| Decision Date | 12/07/2012 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Orthopedic
|
|---|
| Review Advisory Committee |
General & Plastic Surgery
|
|---|
| summary |
summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
