Device Classification Name |
tubes, vials, systems, serum separators, blood collection
|
510(k) Number |
K123987 |
Device Name |
IMPROVE BLOOD COLLECTION SET AND IMPROSAFE BLOOD COLLECTION SET |
Applicant |
INNOVATIVE MEDICAL TECHNOLOGIES, INC. |
15059 CEDAR ST. |
LEAWOOD,
KS
66224
|
|
Applicant Contact |
BRAD BROWN |
Correspondent |
INNOVATIVE MEDICAL TECHNOLOGIES, INC. |
15059 CEDAR ST. |
LEAWOOD,
KS
66224
|
|
Correspondent Contact |
BRAD BROWN |
Regulation Number | 862.1675
|
Classification Product Code |
|
Date Received | 12/26/2012 |
Decision Date | 08/27/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|