Device Classification Name |
Needle, Conduction, Anesthetic (W/Wo Introducer)
|
510(k) Number |
K083909 |
Device Name |
SPINAL INJECTION SYSTEM |
Applicant |
LAURIMED LLC |
500 ARGUELLO STREET, SUITE 100 |
REDWOOD CITY,
CA
94063
|
|
Applicant Contact |
SEVRINA CIUCCI |
Correspondent |
LAURIMED LLC |
500 ARGUELLO STREET, SUITE 100 |
REDWOOD CITY,
CA
94063
|
|
Correspondent Contact |
SEVRINA CIUCCI |
Regulation Number | 868.5150
|
Classification Product Code |
|
Date Received | 12/30/2008 |
Decision Date | 03/18/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|