The following data is part of a premarket notification filed by Sedat with the FDA for Sedat Flamingo.
| Device ID | K082755 |
| 510k Number | K082755 |
| Device Name: | SEDAT FLAMINGO |
| Classification | Syringe, Balloon Inflation |
| Applicant | SEDAT 8895 TOWNE CENTRE DRIVE 105-416 San Diego, CA 92122 |
| Contact | Charles Cousin |
| Correspondent | Charles Cousin SEDAT 8895 TOWNE CENTRE DRIVE 105-416 San Diego, CA 92122 |
| Product Code | MAV |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-19 |
| Decision Date | 2008-12-15 |
| Summary: | summary |