| Device Classification Name |
Anesthesia Conduction Kit
|
| 510(k) Number |
K931670 |
| Device Name |
CARAPACE EPIDURAL BLOCK & SPINAL MYELOGRAM TRAYS |
| Applicant |
| Carapace, Inc. |
| 2701 W Concord St. |
|
Broken Arrow,
OK
74012
|
|
| Applicant Contact |
JERRY W MYERS |
| Correspondent |
| Carapace, Inc. |
| 2701 W Concord St. |
|
Broken Arrow,
OK
74012
|
|
| Correspondent Contact |
JERRY W MYERS |
| Regulation Number | 868.5140 |
| Classification Product Code |
|
| Date Received | 04/06/1993 |
| Decision Date | 01/25/1994 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|