Device Classification Name |
stimulator, nerve, peripheral, electric
|
510(k) Number |
K955031 |
Device Name |
MAXISTIM |
Applicant |
LIFE-TECH INTL., INC. |
P.O. BOX 36221 |
HOUSTON,
TX
77236 -6221
|
|
Applicant Contact |
ALFRED C COATS |
Correspondent |
LIFE-TECH INTL., INC. |
P.O. BOX 36221 |
HOUSTON,
TX
77236 -6221
|
|
Correspondent Contact |
ALFRED C COATS |
Regulation Number | 868.2775
|
Classification Product Code |
|
Date Received | 11/02/1995 |
Decision Date | 12/10/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|