Device Classification Name |
needle, hypodermic, single lumen
|
510(k) Number |
K141117 |
Device Name |
EZ-IO INTRAOSSEOUS INFUSION SYSTEM |
Applicant |
VIDACARE LLC |
4350 LOCKHILL SELMA RD. |
SHAVANO PARK,
TX
78249
|
|
Applicant Contact |
DIANA F MONTEZ, BSN, RN |
Correspondent |
VIDACARE LLC |
4350 LOCKHILL SELMA RD. |
SHAVANO PARK,
TX
78249
|
|
Correspondent Contact |
DIANA F MONTEZ, BSN, RN |
Regulation Number | 880.5570
|
Classification Product Code |
|
Date Received | 04/30/2014 |
Decision Date | 07/08/2014 |
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
|
Recalls |
CDRH Recalls
|
|
|