Device Classification Name |
anesthesia conduction kit
|
510(k) Number |
K060186 |
Device Name |
POLYPLEX STIMULATING CATHETER SYSTEM |
Applicant |
TE ME NA SAS |
962 ALLEGRO LANE |
APOLLO BEACH,
FL
33572
|
|
Applicant Contact |
ARTHUR WARD |
Correspondent |
TE ME NA SAS |
962 ALLEGRO LANE |
APOLLO BEACH,
FL
33572
|
|
Correspondent Contact |
ARTHUR WARD |
Regulation Number | 868.5140
|
Classification Product Code |
|
Date Received | 01/24/2006 |
Decision Date | 07/18/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|