Device Classification Name |
Needle, Hypodermic, Single Lumen
|
510(k) Number |
K132233 |
Device Name |
K-PACK II NEEDLE - 27G X 3/4 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 | 07/18/2013 |
Decision Date | 09/06/2013 |
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
|
|
|