The following data is part of a premarket notification filed by Global Scientific Technologies, Llc with the FDA for Citricon Liquid And Powder (acid Concentrate Acidified With Citric Acid), Aceticon Liquid And Powder (acid Concentrate Acidified With Acetic Acid Or Na Di Acetate), Bicarbocon Liquid And Powder (bicarb Concentrate), Renacon Liquid And Powder (acetate.
| Device ID | K180679 |
| 510k Number | K180679 |
| Device Name: | CitriCon Liquid And Powder (Acid Concentrate Acidified With Citric Acid), AcetiCon Liquid And Powder (Acid Concentrate Acidified With Acetic Acid Or Na Di Acetate), BicarboCon Liquid And Powder (Bicarb Concentrate), RenaCon Liquid And Powder (Acetate |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | Global Scientific Technologies, LLC 151 Old Jones Road Greer, SC 29651 |
| Contact | William J. Griswold, Jr. |
| Correspondent | William J. Griswold, Jr. Global Scientific Technologies, LLC P.O Box 1347 Duncan, SC 29334 -1347 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-15 |
| Decision Date | 2018-12-07 |
| Summary: | summary |