The following data is part of a premarket notification filed by Sedat S.a. with the FDA for Dolphin Inflation Device.
| Device ID | K042449 |
| 510k Number | K042449 |
| Device Name: | DOLPHIN INFLATION DEVICE |
| Classification | Syringe, Balloon Inflation |
| Applicant | SEDAT S.A. 45900 PARSIPPANY COURT Temecula, CA 92592 |
| Contact | Laetitia Bernard |
| Correspondent | Laetitia Bernard SEDAT S.A. 45900 PARSIPPANY COURT Temecula, CA 92592 |
| Product Code | MAV |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-09 |
| Decision Date | 2005-04-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 23661234017533 | K042449 | 000 |
| 23661234017526 | K042449 | 000 |
| 23661234017366 | K042449 | 000 |