The following data is part of a premarket notification filed by Medical Device Support Services with the FDA for Prism Medical Custom Dialysis Kit.
| Device ID | K941803 |
| 510k Number | K941803 |
| Device Name: | PRISM MEDICAL CUSTOM DIALYSIS KIT |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| Applicant | MEDICAL DEVICE SUPPORT SERVICES 4840 PORTSMOUTH BLVD. El Paso, TX 79922 |
| Contact | Walter Mcquade |
| Correspondent | Walter Mcquade MEDICAL DEVICE SUPPORT SERVICES 4840 PORTSMOUTH BLVD. El Paso, TX 79922 |
| Product Code | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-12 |
| Decision Date | 1995-01-30 |