The following data is part of a premarket notification filed by Dideco S.p.a. with the FDA for Dideco D920, Lilliput 1 Twin Reservoir.
| Device ID | K984322 |
| 510k Number | K984322 |
| Device Name: | DIDECO D920, LILLIPUT 1 TWIN RESERVOIR |
| Classification | Defoamer, Cardiopulmonary Bypass |
| Applicant | DIDECO S.P.A. 1601 TRAPELO RD. Waltham, MA 02154 |
| Contact | Barry Sall |
| Correspondent | Barry Sall DIDECO S.P.A. 1601 TRAPELO RD. Waltham, MA 02154 |
| Product Code | DTP |
| CFR Regulation Number | 870.4230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-03 |
| Decision Date | 1999-03-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38033178250222 | K984322 | 000 |