Device Classification Name |
Needle, Conduction, Anesthetic (W/Wo Introducer)
|
510(k) Number |
K043500 |
Device Name |
FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) SYSTEM, INCLUDING FAD CATHETER KIT AND FAD INTRODUCER NEEDLE |
Applicant |
INNOSPINE, INC. |
11240 MAGDALENA ROAD |
LOS ALTOS HILLS,
CA
94024
|
|
Applicant Contact |
LARAINE PANGELINA |
Correspondent |
INNOSPINE, INC. |
11240 MAGDALENA ROAD |
LOS ALTOS HILLS,
CA
94024
|
|
Correspondent Contact |
LARAINE PANGELINA |
Regulation Number | 868.5150
|
Classification Product Code |
|
Date Received | 12/20/2004 |
Decision Date | 04/15/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|