Device Classification Name |
Needle, Hypodermic, Single Lumen
|
510(k) Number |
K122249 |
Device Name |
TERUMO SURGUARD3 SAFETY NEEDLE & HYPODERMIC SYRINGE WITH SAFETY NEEDLE |
Applicant |
TERUMO (PHILIPPINES) CORPORATION |
950 ELKTON BLVD |
ELKTON,
MD
21921
|
|
Applicant Contact |
PHILLIP LESTER |
Correspondent |
TERUMO (PHILIPPINES) CORPORATION |
950 ELKTON BLVD |
ELKTON,
MD
21921
|
|
Correspondent Contact |
PHILLIP LESTER |
Regulation Number | 880.5570
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/27/2012 |
Decision Date | 08/28/2012 |
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
|
|
|