The following data is part of a premarket notification filed by Mar Cor Services, Inc. with the FDA for Mar Cor Services Bicarb System.
| Device ID | K003560 |
| 510k Number | K003560 |
| Device Name: | MAR COR SERVICES BICARB SYSTEM |
| Classification | Tank, Holding, Dialysis |
| Applicant | MAR COR SERVICES, INC. 364 MAPLE AVE. Harleysville, PA 19438 |
| Contact | Michael Robertson |
| Correspondent | Michael Robertson MAR COR SERVICES, INC. 364 MAPLE AVE. Harleysville, PA 19438 |
| Product Code | FIN |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-17 |
| Decision Date | 2001-06-08 |