The following data is part of a premarket notification filed by Dideco S.p.a. with the FDA for Autologous Blood Management System (abms).
| Device ID | K982650 |
| 510k Number | K982650 |
| Device Name: | AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS) |
| Classification | Apparatus, Autotransfusion |
| Applicant | DIDECO S.P.A. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Rosina Robinson |
| Correspondent | Rosina Robinson DIDECO S.P.A. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-30 |
| Decision Date | 1998-12-16 |
| Summary: | summary |