Device Classification Name |
needle, hypodermic, single lumen
|
510(k) Number |
K152877 |
Device Name |
SureFine Pen Needle |
Applicant |
SHINA MED CORPORATION |
455-30, BOGAEWONSAM-RO, BOGAE-MYUN |
ANSEONG-SI,
KR
456-871
|
|
Applicant Contact |
SUNG-SOON PARK |
Correspondent |
LK CONSULTING GROUP USA, INC. |
2651 E CHAPMAN AVE STE 110 |
FULLERTON,
CA
92831
|
|
Correspondent Contact |
PRISCILLA CHUNG |
Regulation Number | 880.5570
|
Classification Product Code |
|
Date Received | 09/30/2015 |
Decision Date | 06/07/2016 |
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
|
|
|