| Device Classification Name |
injector and syringe, angiographic |
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|---|---|---|---|---|
| 510(k) Number | K131478 | |||
| Device Name | CONTRAST CONSERVATION SYSTEM | |||
| Applicant |
|
|||
| Applicant Contact | jill munsinger | |||
| Regulation Number | 870.1650 | |||
| Classification Product Code |
|
|||
| Date Received | 05/22/2013 | |||
| Decision Date | 08/15/2013 | |||
| Decision |
substantially equivalent (SESE) |
|||
| Regulation Medical Specialty |
Cardiovascular |
|||
| 510k Review Panel |
Cardiovascular |
|||
| summary |
summary |
|||
| Type | Traditional | |||
| Reviewed by Third Party | Yes | |||
| Combination Product |
No |