The following data is part of a premarket notification filed by Hospal Medical Corp. with the FDA for Hospal Dialysate For Cavhd.
| Device ID | K861156 |
| 510k Number | K861156 |
| Device Name: | HOSPAL DIALYSATE FOR CAVHD |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | HOSPAL MEDICAL CORP. 25 KIMBERLY RD. P.O. BOX 857 East Brunswick, NJ 08816 |
| Contact | Catherina Madormo |
| Correspondent | Catherina Madormo HOSPAL MEDICAL CORP. 25 KIMBERLY RD. P.O. BOX 857 East Brunswick, NJ 08816 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-28 |
| Decision Date | 1986-09-23 |