Device Classification Name |
catheter, conduction, anesthetic
|
510(k) Number |
K171193 |
Device Name |
Certa Catheter |
Applicant |
Ferrosan Medical Devices SP. Z O.O. |
Koksowa 3 |
Szczecin,
PL
70-031
|
|
Applicant Contact |
Elzbieta Porebska-Guillemant |
Correspondent |
Ferrosan Medical Devices SP. Z.O.O. c/o Promedic LLC |
24301 Woodsage Dr. |
Bonita Springs,
FL
34134 -2958
|
|
Correspondent Contact |
Paul Dryden |
Regulation Number | 868.5120
|
Classification Product Code |
|
Date Received | 04/24/2017 |
Decision Date | 12/18/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|