The following data is part of a premarket notification filed by Dimesol Usa, Llc with the FDA for Citric Complete Dry Citric Acid (45x).
| Device ID | K171750 |
| 510k Number | K171750 |
| Device Name: | Citric Complete Dry Citric Acid (45X) |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | Dimesol USA, LLC 509 Fishing Creek Road Lewisberry, PA 17339 |
| Contact | Marlene Van Dyke |
| Correspondent | David M. Marcus McNees Wallace & Nurick 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 | 2017-06-13 |
| Decision Date | 2018-03-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817411021186 | K171750 | 000 |
| 00817411021209 | K171750 | 000 |
| 00817411021193 | K171750 | 000 |
| 00817411021360 | K171750 | 000 |
| 00817411021353 | K171750 | 000 |
| 00817411021346 | K171750 | 000 |
| 00817411021339 | K171750 | 000 |
| 00817411021322 | K171750 | 000 |
| 00817411021315 | K171750 | 000 |
| 00817411021308 | K171750 | 000 |
| 00817411021292 | K171750 | 000 |
| 00817411021285 | K171750 | 000 |
| 00817411021216 | K171750 | 000 |
| 00817411021223 | K171750 | 000 |
| 00817411021230 | K171750 | 000 |
| 00817411021179 | K171750 | 000 |
| 00817411021162 | K171750 | 000 |
| 00817411021155 | K171750 | 000 |
| 00817411021148 | K171750 | 000 |
| 00817411021131 | K171750 | 000 |
| 00817411021124 | K171750 | 000 |
| 00817411021117 | K171750 | 000 |
| 00817411021100 | K171750 | 000 |
| 00817411021261 | K171750 | 000 |
| 00817411021254 | K171750 | 000 |
| 00817411021247 | K171750 | 000 |
| 00817411021278 | K171750 | 000 |