Device Classification Name |
Needle, Hypodermic, Single Lumen
|
510(k) Number |
K152362 |
Device Name |
Terumo SurGuard 3 Safety Hypodermic Needle |
Applicant |
TERUMO (PHILIPPINES) CORPORATION |
124 EAST MAIN AVENUE, LAGUNA TECHNOPARK |
BINAN,
PH
|
|
Applicant Contact |
PHEBE VARGHESE |
Correspondent |
TERUMO MEDICAL CORPORATION |
265 DAVIDSON AVENUE, SUITE 320 |
SOMERSET,
NJ
08873
|
|
Correspondent Contact |
PHEBE VARGHESE |
Regulation Number | 880.5570
|
Classification Product Code |
|
Date Received | 08/20/2015 |
Decision Date | 10/16/2015 |
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
|
|
|