The following data is part of a premarket notification filed by Dideco S.p.a. with the FDA for Dhf 0.2 Hemoconcentrator: Dideco Newborn-infant Hemoncentration; Dhr 0.6 Hemoconcentrator: Dideco Pediatric/small Adult.
| Device ID | K021732 |
| 510k Number | K021732 |
| Device Name: | DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION; DHR 0.6 HEMOCONCENTRATOR: DIDECO PEDIATRIC/SMALL ADULT |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | DIDECO S.P.A. 195 WEST ST. Waltham, MA 02451 -1163 |
| Contact | Barry Sall |
| Correspondent | Barry Sall DIDECO S.P.A. 195 WEST ST. Waltham, MA 02451 -1163 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-24 |
| Decision Date | 2002-11-04 |
| Summary: | summary |