The following data is part of a premarket notification filed by Biopharm, Inc. with the FDA for Acid Concentrate Solutions.
| Device ID | K910319 |
| 510k Number | K910319 |
| Device Name: | ACID CONCENTRATE SOLUTIONS |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | BIOPHARM, INC. C/O MEDICAL COMPONENTS, INC. 1499 DELP DRIVE Harleysville, PA 19438 |
| Contact | Rachel D Richardson |
| Correspondent | Rachel D Richardson BIOPHARM, INC. C/O MEDICAL COMPONENTS, INC. 1499 DELP DRIVE 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 | 1991-01-24 |
| Decision Date | 1991-04-24 |