Device Classification Name |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
|
510(k) Number |
K113622 |
Device Name |
ORION II CT CVC |
Applicant |
HEALTH LINE INTERNATIONAL CORPORATION (HLIC) |
803 North 1250 West |
Suite 1 |
Centerville,
UT
84014
|
|
Applicant Contact |
NOLA BENSTOG |
Correspondent |
HEALTH LINE INTERNATIONAL CORPORATION (HLIC) |
803 North 1250 West |
Suite 1 |
Centerville,
UT
84014
|
|
Correspondent Contact |
NOLA BENSTOG |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 12/08/2011 |
Decision Date | 05/18/2012 |
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
|
|
|