Device Classification Name |
needle, hypodermic, single lumen
|
510(k) Number |
K132583 |
Device Name |
EZ-IO INTRAOSSEOUS INFUSION SYSTEM |
Applicant |
VIDACARE CORPORATION |
4350 LOCKHILL SELMA ROAD |
SHAVANO PARK,
TX
78249 -2095
|
|
Applicant Contact |
LARRY J MILLER |
Correspondent |
VIDACARE CORPORATION |
4350 LOCKHILL SELMA ROAD |
SHAVANO PARK,
TX
78249 -2095
|
|
Correspondent Contact |
LARRY J MILLER |
Regulation Number | 880.5570
|
Classification Product Code |
|
Date Received | 08/16/2013 |
Decision Date | 02/11/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|