Device Classification Name |
Needle, Hypodermic, Single Lumen
|
510(k) Number |
K072059 |
Device Name |
GRIPPER MICRO NEEDLE |
Applicant |
SMITHS MEDICAL MD, INC. |
1265 GREY FOX RD. |
ARDEN HILLS,
MN
55112
|
|
Applicant Contact |
BRIAN L HAUGSTAD |
Correspondent |
SMITHS MEDICAL MD, INC. |
1265 GREY FOX RD. |
ARDEN HILLS,
MN
55112
|
|
Correspondent Contact |
BRIAN L HAUGSTAD |
Regulation Number | 880.5570
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/26/2007 |
Decision Date | 11/01/2007 |
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
|
|
|