The following data is part of a premarket notification filed by Mar Cor Services, Inc. with the FDA for Mar Cor Complete Water Treatment System For Kdney Dialysis.
| Device ID | K945559 |
| 510k Number | K945559 |
| Device Name: | MAR COR COMPLETE WATER TREATMENT SYSTEM FOR KDNEY DIALYSIS |
| Classification | Subsystem, Water Purification |
| Applicant | MAR COR SERVICES, INC. 364 MAPLE AVE. Harleysville, PA 19438 |
| Contact | Deborah W Blum |
| Correspondent | Deborah W Blum MAR COR SERVICES, INC. 364 MAPLE AVE. Harleysville, PA 19438 |
| Product Code | FIP |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-10 |
| Decision Date | 1996-05-28 |
| Summary: | summary |