| Device Classification Name |
Anesthesia Conduction Kit
|
| 510(k) Number |
K851134 |
| Device Name |
REGIONAL ANESTHESIA TRAYS |
| Applicant |
| Concord Laboratories, Inc. |
| Kit St. |
|
Keene,
NH
03431
|
|
| Applicant Contact |
ROBERT WHEELER |
| Correspondent |
| Concord Laboratories, Inc. |
| Kit St. |
|
Keene,
NH
03431
|
|
| Correspondent Contact |
ROBERT WHEELER |
| Regulation Number | 868.5140 |
| Classification Product Code |
|
| Date Received | 03/21/1985 |
| Decision Date | 07/15/1985 |
| Decision |
Substantially Equivalent - With Drug
(SESD) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|