The following data is part of a premarket notification filed by Dideco with the FDA for Dideco Compact-a Autotransfusion System.
| Device ID | K940519 |
| 510k Number | K940519 |
| Device Name: | DIDECO COMPACT-A AUTOTRANSFUSION SYSTEM |
| Classification | Apparatus, Autotransfusion |
| Applicant | DIDECO 49 PLAIN ST. North Attleboro, MA 02760 -4153 |
| Contact | Rosina Robinson, R.n. |
| Correspondent | Rosina Robinson, R.n. DIDECO 49 PLAIN ST. North Attleboro, MA 02760 -4153 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-04 |
| Decision Date | 1995-01-19 |