Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K040527 |
Device Name |
LOW PROFILE LUTHER SAFETY HUBER |
Applicant |
LUTHER NEEDLESAFE PRODUCTS, INC. |
3722 AVE. SAUSALITO |
IRVINE,
CA
92606
|
|
Applicant Contact |
GREG HOLLAND |
Correspondent |
LUTHER NEEDLESAFE PRODUCTS, INC. |
3722 AVE. SAUSALITO |
IRVINE,
CA
92606
|
|
Correspondent Contact |
GREG HOLLAND |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 03/01/2004 |
Decision Date | 03/26/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|