The following data is part of a premarket notification filed by Dideco S.p.a. with the FDA for Dideco Electa.
| Device ID | K020647 |
| 510k Number | K020647 |
| Device Name: | DIDECO ELECTA |
| 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 | 2002-02-28 |
| Decision Date | 2002-09-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38033178105591 | K020647 | 000 |
| 38033178105201 | K020647 | 000 |
| 38033178105188 | K020647 | 000 |
| 38033178105164 | K020647 | 000 |
| 38033178105140 | K020647 | 000 |