The following data is part of a premarket notification filed by Hospal Medical Corp. with the FDA for Monitral S Gs Hemodialysis Single Patient Unit.
| Device ID | K871218 |
| 510k Number | K871218 |
| Device Name: | MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT |
| Classification | System, Dialysate Delivery, Single Patient |
| Applicant | HOSPAL MEDICAL CORP. 21 NORTHFIELD AVE. RARITAN CENTER Edison, NJ 08837 |
| Contact | J. L Fressinet |
| Correspondent | J. L Fressinet HOSPAL MEDICAL CORP. 21 NORTHFIELD AVE. RARITAN CENTER Edison, NJ 08837 |
| Product Code | FKP |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-27 |
| Decision Date | 1987-04-30 |