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 |