Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K112512 |
Device Name |
VANISHPOINT BLOOD COLLECTION SET |
Applicant |
RETRACTABLE TECHNOLOGIES, INC. |
511 LOBO LN. |
LITTLE ELM,
TX
75068 -0009
|
|
Applicant Contact |
RHONDA WELLS |
Correspondent |
RETRACTABLE TECHNOLOGIES, INC. |
511 LOBO LN. |
LITTLE ELM,
TX
75068 -0009
|
|
Correspondent Contact |
RHONDA WELLS |
Regulation Number | 880.5440
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/30/2011 |
Decision Date | 10/20/2011 |
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
|
|
|