Device Classification Name |
Needle, Hypodermic, Single Lumen
|
510(k) Number |
K151398 |
Device Name |
K-Pack II Needle - 29G x 5/16 Thin Wall |
Applicant |
TERUMO EUROPE N.V. |
Interleuvenlaan 40 |
Leuven,
BE
3001
|
|
Applicant Contact |
M. J. Aerts |
Correspondent |
TERUMO EUROPE N.V. |
Interleuvenlaan 40 |
Leuven,
BE
3001
|
|
Correspondent Contact |
M. J. Aerts |
Regulation Number | 880.5570
|
Classification Product Code |
|
Date Received | 05/26/2015 |
Decision Date | 06/25/2015 |
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
|
|
|