Device Classification Name |
Stimulator, Nerve, Transcutaneous, For Pain Relief
|
510(k) Number |
K860847 |
Device Name |
WALLANT NEUROLOGIX GENERAL PURPOSE TENS |
Applicant |
WALLANT INTL. TRADE, INC. |
312 - 314 COX ST. |
ROSELLE,
NJ
07203
|
|
Applicant Contact |
ELMER ARLUCK |
Correspondent |
WALLANT INTL. TRADE, INC. |
312 - 314 COX ST. |
ROSELLE,
NJ
07203
|
|
Correspondent Contact |
ELMER ARLUCK |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 03/06/1986 |
Decision Date | 08/07/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|