The following data is part of a premarket notification filed by Ash Medical Systems, Inc. with the FDA for Modified Bio. Hemodialysis & Hd-1000 Disp. Cart..
| Device ID | K870270 |
| 510k Number | K870270 |
| Device Name: | MODIFIED BIO. HEMODIALYSIS & HD-1000 DISP. CART. |
| Classification | System, Dialysate Delivery, Sorbent Regenerated |
| Applicant | ASH MEDICAL SYSTEMS, INC. 2701 B KENT AVE. West Lafayette, IN 47906 |
| Contact | Ash, M.d. |
| Correspondent | Ash, M.d. 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 | 1987-01-27 |
| Decision Date | 1987-02-25 |