The following data is part of a premarket notification filed by Althin Medical Ab An Affiliate Of Baxter Intl with the FDA for Drake Willock System & Altra Touch 1000 Dialysis Delivery System.
| Device ID | K970446 |
| 510k Number | K970446 |
| Device Name: | DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEM |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL 13520 S.E. PHEASANT COURT Portland, OR 97222 -1298 |
| Contact | Thomas D Kelly |
| Correspondent | Thomas D Kelly ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL 13520 S.E. PHEASANT COURT Portland, OR 97222 -1298 |
| Product Code | KDI |
| Subsequent Product Code | JPI |
| Subsequent Product Code | MQS |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-05 |
| Decision Date | 1997-06-02 |
| Summary: | summary |