The following data is part of a premarket notification filed by Delmed, Inc. with the FDA for Hospal Dialysate For C.a.v.h.d..
| Device ID | K872857 |
| 510k Number | K872857 |
| Device Name: | HOSPAL DIALYSATE FOR C.A.V.H.D. |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | DELMED, INC. P.O. DRAWER 190 Freehold, NJ 07728 |
| Contact | A. P Doerschuk |
| Correspondent | A. P Doerschuk DELMED, INC. P.O. DRAWER 190 Freehold, NJ 07728 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-21 |
| Decision Date | 1987-10-05 |