| Device Classification Name |
Needle, Conduction, Anesthetic (W/Wo Introducer)
|
| 510(k) Number |
K050499 |
| Device Name |
PROBLOC, HN SERIES AND PROLONG, PL SERIES |
| Applicant |
| Life-Tech, Inc. |
| 4235 Greenbriar Dr. |
|
Stafford,
TX
77477 -3995
|
|
| Applicant Contact |
JEFF KASOFF |
| Correspondent |
| Life-Tech, Inc. |
| 4235 Greenbriar Dr. |
|
Stafford,
TX
77477 -3995
|
|
| Correspondent Contact |
JEFF KASOFF |
| Regulation Number | 868.5150 |
| Classification Product Code |
|
| Date Received | 02/28/2005 |
| Decision Date | 05/17/2005 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Statement |
Statement
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|