Device Classification Name |
Catheter, Conduction, Anesthetic
|
510(k) Number |
K081404 |
Device Name |
SPINAL INTEGRATION SPINAL-EZE INTRAOPERATIVE EPIDURAL CATHETER KIT |
Applicant |
SPINAL INTEGRATION LLC |
6314 KINGSPOINTE PKWY UNIT 6 |
ORLANDO,
FL
32819
|
|
Applicant Contact |
TRUDIE L SEEGER |
Correspondent |
SPINAL INTEGRATION LLC |
6314 KINGSPOINTE PKWY UNIT 6 |
ORLANDO,
FL
32819
|
|
Correspondent Contact |
TRUDIE L SEEGER |
Regulation Number | 868.5120
|
Classification Product Code |
|
Date Received | 05/19/2008 |
Decision Date | 10/21/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|