Device Classification Name |
Needle, Hypodermic, Single Lumen
|
510(k) Number |
K121607 |
Device Name |
TERUMO(R) NEEDLE |
Applicant |
TERUMO (PHILIPPINES) CORPORATION |
950 ELKTON BLVD |
ELKTON,
MD
21921
|
|
Applicant Contact |
SANDI HARTKA |
Correspondent |
TERUMO (PHILIPPINES) CORPORATION |
950 ELKTON BLVD |
ELKTON,
MD
21921
|
|
Correspondent Contact |
SANDI HARTKA |
Regulation Number | 880.5570
|
Classification Product Code |
|
Date Received | 06/01/2012 |
Decision Date | 11/08/2012 |
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
|
Recalls |
CDRH Recalls
|
|
|