Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K120548 |
Device Name |
HLIC NEEDLE-LESS VALVE |
Applicant |
HEALTH LINE INTERNATIONAL CORPORATION |
803 N. 1250 W. |
SUITE 1 |
CENTERVILLE,
UT
84014
|
|
Applicant Contact |
NOLA BENSTOG |
Correspondent |
HEALTH LINE INTERNATIONAL CORPORATION |
803 N. 1250 W. |
SUITE 1 |
CENTERVILLE,
UT
84014
|
|
Correspondent Contact |
NOLA BENSTOG |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 02/23/2012 |
Decision Date | 05/04/2012 |
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
|
|
|