The following data is part of a premarket notification filed by Dialysis Medical Solutions, Llc with the FDA for Medicalyte(r) Bicarbonate Powder (36.83x), Medicalyte(r) Bicarbonate Powder (45x), Medicalyte(r) Bicarbonate Powder (35x.
| Device ID | K131202 |
| 510k Number | K131202 |
| Device Name: | MEDICALYTE(R) BICARBONATE POWDER (36.83X), MEDICALYTE(R) BICARBONATE POWDER (45X), MEDICALYTE(R) BICARBONATE POWDER (35X |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | DIALYSIS MEDICAL SOLUTIONS, LLC 21 EAST STATE STREET SUITE 1700 Columbus, OH 43215 |
| Contact | Courtney J Miller |
| Correspondent | Courtney J Miller DIALYSIS MEDICAL SOLUTIONS, LLC 21 EAST STATE STREET SUITE 1700 Columbus, OH 43215 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-29 |
| Decision Date | 2014-04-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10817411020322 | K131202 | 000 |
| 10817411020278 | K131202 | 000 |
| 10817411022418 | K131202 | 000 |
| 10817411022401 | K131202 | 000 |
| 10817411022395 | K131202 | 000 |
| 10817411022807 | K131202 | 000 |
| 10817411022791 | K131202 | 000 |
| 10817411022784 | K131202 | 000 |