Device Classification Name |
interventional fluoroscopic x-ray system
|
510(k) Number |
K132305 |
Device Name |
STENTBOOST REL. 4 |
Applicant |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
VEENPLUIS 4-6 |
BEST,
NL
5684 PC
|
|
Applicant Contact |
LISELOTTE KORNMANN |
Correspondent |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
VEENPLUIS 4-6 |
BEST,
NL
5684 PC
|
|
Correspondent Contact |
LISELOTTE KORNMANN |
Regulation Number | 892.1650
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/24/2013 |
Decision Date | 10/30/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|