| Device Classification Name |
Anesthesia Conduction Kit
|
| 510(k) Number |
K934526 |
| Device Name |
MICRO-SP CUSTOM SPINAL ANESTHESIA TRAY |
| Applicant |
| Neurodelivery Technology, Inc. |
| P.O. Box 548 Chiron Springs |
| Offices, Etna Rd. |
|
Lebanon,
NH
03766
|
|
| Applicant Contact |
DENNIS W COOMBS |
| Correspondent |
| Neurodelivery Technology, Inc. |
| P.O. Box 548 Chiron Springs |
| Offices, Etna Rd. |
|
Lebanon,
NH
03766
|
|
| Correspondent Contact |
DENNIS W COOMBS |
| Regulation Number | 868.5140 |
| Classification Product Code |
|
| Date Received | 09/20/1993 |
| Decision Date | 01/28/1994 |
| 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
|
|
|