The following data is part of a premarket notification filed by Sedat with the FDA for Sedat Myshell Lite.
| Device ID | K080472 |
| 510k Number | K080472 |
| Device Name: | SEDAT MYSHELL LITE |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | SEDAT 8895 TOWNE CENTRE DRIVE 105-416 San Diego, CA |
| Contact | Laetitia Cousin |
| Correspondent | Laetitia Cousin SEDAT 8895 TOWNE CENTRE DRIVE 105-416 San Diego, CA |
| Product Code | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-21 |
| Decision Date | 2008-04-23 |
| Summary: | summary |