The following data is part of a premarket notification filed by Ash Medical Systems, Inc. with the FDA for Modified Biologic 1000 Hemodial. & Hd-1000 Dis Car.
| Device ID | K874137 |
| 510k Number | K874137 |
| Device Name: | MODIFIED BIOLOGIC 1000 HEMODIAL. & HD-1000 DIS CAR |
| Classification | System, Dialysate Delivery, Sorbent Regenerated |
| Applicant | ASH MEDICAL SYSTEMS, INC. 2701 B KENT AVE. West Lafayette, IN 47906 |
| Contact | Ash, Md |
| Correspondent | Ash, Md ASH MEDICAL SYSTEMS, INC. 2701 B KENT AVE. West Lafayette, IN 47906 |
| Product Code | FKT |
| CFR Regulation Number | 876.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-13 |
| Decision Date | 1988-04-08 |