| Device Classification Name |
Needle, Conduction, Anesthetic (W/Wo Introducer)
|
| 510(k) Number |
K952275 |
| Device Name |
GLOBAL MEDICAL PRODUCTS TUOHY & CRAWFORD EPIDURAL NEEDLE W/PLASTIC HUB |
| Applicant |
| Global Medical Prods, Inc. |
| 2230 Nursery Rd. |
| Unit D41 |
|
Clearwater,
FL
34624
|
|
| Applicant Contact |
DONALD F RYAN |
| Correspondent |
| Global Medical Prods, Inc. |
| 2230 Nursery Rd. |
| Unit D41 |
|
Clearwater,
FL
34624
|
|
| Correspondent Contact |
DONALD F RYAN |
| Regulation Number | 868.5150 |
| Classification Product Code |
|
| Date Received | 05/15/1995 |
| Decision Date | 10/11/1995 |
| 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
|
|
|