Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K101180 |
Device Name |
GRIPPER MICRO BLUNT CANNULA, NON-CORING SAFETY NEEDLE (GRIPPER MICRO NEEDLE) MODEL: 21-3253-24, 21-3258-24, 21-3262-24, |
Applicant |
SMITHS MEDICAL MD, INC. |
1265 GREY FOX RD. |
ST. PAUL,
MN
55112
|
|
Applicant Contact |
SAINT PAUL |
Correspondent |
SMITHS MEDICAL MD, INC. |
1265 GREY FOX RD. |
ST. PAUL,
MN
55112
|
|
Correspondent Contact |
SAINT PAUL |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 04/27/2010 |
Decision Date | 08/03/2010 |
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
|
|
|