| Device Classification Name |
anesthesia conduction kit
|
|---|
| 510(k) Number |
K895192 |
|---|
| Device Name |
SPINOCAN(R) CONTINUOUS SPINAL TRAY |
|---|
| Applicant |
| BURRON MEDICAL, INC. |
| 824 TWELFTH AVE. |
|
BETHLEHEM,
PA
18018
|
|
| Applicant Contact |
PEGGY KEIFFER |
| Correspondent |
| BURRON MEDICAL, INC. |
| 824 TWELFTH AVE. |
|
BETHLEHEM,
PA
18018
|
|
| Correspondent Contact |
PEGGY KEIFFER |
| Regulation Number | 868.5140
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 08/11/1989 |
|---|
| Decision Date | 09/18/1989 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Anesthesiology
|
|---|
| 510k Review Panel |
Anesthesiology
|
|---|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|