| Device Classification Name |
Anesthesia Conduction Kit
|
| 510(k) Number |
K892660 |
| Device Name |
HIBERNATION KIT |
| Applicant |
| Devon Industries, Inc. |
| 9530 De Soto Ave. |
|
Chatsworth,
CA
91311
|
|
| Applicant Contact |
ROBERT T HORAN |
| Correspondent |
| Devon Industries, Inc. |
| 9530 De Soto Ave. |
|
Chatsworth,
CA
91311
|
|
| Correspondent Contact |
ROBERT T HORAN |
| Regulation Number | 868.5140 |
| Classification Product Code |
|
| Date Received | 04/13/1989 |
| Decision Date | 08/15/1989 |
| 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
|
|
|