The following data is part of a premarket notification filed by Medical Components, Inc. with the FDA for Acetate Concentrates For Hemodialysis.
| Device ID | K905021 |
| 510k Number | K905021 |
| Device Name: | ACETATE CONCENTRATES FOR HEMODIALYSIS |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | MEDICAL COMPONENTS, INC. 1499 DELP DR. Harleysville, PA 19438 |
| Contact | Rachel D Richardson |
| Correspondent | Rachel D Richardson MEDICAL COMPONENTS, INC. 1499 DELP DR. Harleysville, PA 19438 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-07 |
| Decision Date | 1991-03-15 |