Device Classification Name |
Catheter, Conduction, Anesthetic
|
510(k) Number |
K161232 |
Device Name |
ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit |
Applicant |
HALYARD HEALTH |
5405 WINDWARD PARKWAY |
ALPHARETTA,
GA
30004
|
|
Applicant Contact |
GWENDOLYN GEORGE |
Correspondent |
HALYARD HEALTH |
5405 WINDWARD PARKWAY |
ALPHARETTA,
GA
30004
|
|
Correspondent Contact |
GWENDOLYN GEORGE |
Regulation Number | 868.5120
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/02/2016 |
Decision Date | 09/30/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|