| Device Classification Name |
dialyzer, high permeability with or without sealed dialysate system |
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|---|---|---|---|---|---|
| 510(k) Number | K131516 | ||||
| Device Name | PRISMAFLEX SYSTEM 7.10 | ||||
| Applicant |
|
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| Applicant Contact | kae miller | ||||
| Correspondent |
|
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| Correspodent Contact | kae miller | ||||
| Regulation Number | 876.5860 | ||||
| Classification Product Code |
|
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| Date Received | 05/28/2013 | ||||
| Decision Date | 01/03/2014 | ||||
| Decision |
substantially equivalent (SESE) |
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| Regulation Medical Specialty |
Gastroenterology/Urology |
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| 510k Review Panel |
Gastroenterology/Urology |
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| statement |
statement |
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| Type | Traditional | ||||
| Reviewed by Third Party | No | ||||
| Combination Product |
No |