| Device Classification Name |
Needle, Conduction, Anesthetic (W/Wo Introducer)
|
| 510(k) Number |
K813179 |
| Device Name |
PERICAN, EPIDURAL CANNULA |
| Applicant |
| BURRON MEDICAL PRODUCTS, INC. |
| 4221 Richmond Rd., N.W. |
|
Walker,
MI
49534
|
|
| Correspondent |
| BURRON MEDICAL PRODUCTS, INC. |
| 4221 Richmond Rd., N.W. |
|
Walker,
MI
49534
|
|
| Regulation Number | 868.5150 |
| Classification Product Code |
|
| Date Received | 11/12/1981 |
| Decision Date | 12/03/1981 |
| 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
|
|
|