The following data is part of a premarket notification filed by Dove Medical Supplies with the FDA for Hemodialysis Concentrates.
| Device ID | K883068 |
| 510k Number | K883068 |
| Device Name: | HEMODIALYSIS CONCENTRATES |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | DOVE MEDICAL SUPPLIES 315 GRAND BLVD. Vancouver, WA 98661 |
| Contact | Don Cannady |
| Correspondent | Don Cannady DOVE MEDICAL SUPPLIES 315 GRAND BLVD. Vancouver, WA 98661 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-20 |
| Decision Date | 1988-12-22 |