Device Classification Name |
Catheter, Conduction, Anesthetic
|
510(k) Number |
K072050 |
Device Name |
PROLONG-EX, MODELS: PLEX-50CS, PLEX-100CS, PLEX-150CS |
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 | 868.5120
|
Classification Product Code |
|
Date Received | 07/26/2007 |
Decision Date | 10/18/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|