Device Classification Name |
Needle, Hypodermic, Single Lumen
|
510(k) Number |
K041399 |
Device Name |
HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICE |
Applicant |
SMITHS MEDICAL ASD, INC. |
10 BOWMAN DR. |
KEENE,
NH
03431
|
|
Applicant Contact |
BRIAN D FARIAS |
Correspondent |
SMITHS MEDICAL ASD, INC. |
10 BOWMAN DR. |
KEENE,
NH
03431
|
|
Correspondent Contact |
BRIAN D FARIAS |
Regulation Number | 880.5570
|
Classification Product Code |
|
Date Received | 05/26/2004 |
Decision Date | 07/28/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|