Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K073050 |
Device Name |
SAFESTEP MAX POWER-INJECTABLE INFUSION SET |
Applicant |
SPECIALIZED HEALTH PRODUCTS INTERNATIONAL, INC. |
585 WEST 500 SOUTH |
BOUNTIFUL,
UT
84010
|
|
Applicant Contact |
Mark Nelson |
Correspondent |
SPECIALIZED HEALTH PRODUCTS INTERNATIONAL, INC. |
585 WEST 500 SOUTH |
BOUNTIFUL,
UT
84010
|
|
Correspondent Contact |
Mark Nelson |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 10/29/2007 |
Decision Date | 01/25/2008 |
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
|
|
|