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 1000 Dialysate Delivery System W/single Needle Single Lumen Option.
| Device ID | K955384 |
| 510k Number | K955384 |
| Device Name: | DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM W/SINGLE NEEDLE SINGLE LUMEN OPTION |
| 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 | Alan G Lewis |
| Correspondent | Alan G Lewis ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL 13520 S.E. PHEASANT COURT Portland, OR 97222 -1298 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-22 |
| Decision Date | 1997-01-10 |
| Summary: | summary |