The following data is part of a premarket notification filed by Dideco S.p.a. with the FDA for Synthesis Mimesys Adult Membrane Oxygenator.
| Device ID | K031223 |
| 510k Number | K031223 |
| Device Name: | SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| 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 | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-18 |
| Decision Date | 2003-05-02 |
| Summary: | summary |