The following data is part of a premarket notification filed by Fuji Systems Corp. with the FDA for Silbroncho Double Lumen Tube.
| Device ID | K051522 |
| 510k Number | K051522 |
| Device Name: | SILBRONCHO DOUBLE LUMEN TUBE |
| Classification | Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) |
| Applicant | FUJI SYSTEMS CORP. 6329 W. WATERVIEW COURT Mccordsville, IN 46055 -9501 |
| Contact | Paul E Dryden |
| Correspondent | Paul E Dryden FUJI SYSTEMS CORP. 6329 W. WATERVIEW COURT Mccordsville, IN 46055 -9501 |
| Product Code | CBI |
| CFR Regulation Number | 868.5740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-08 |
| Decision Date | 2005-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04544050083959 | K051522 | 000 |
| 14544050123942 | K051522 | 000 |
| 14544050123959 | K051522 | 000 |
| 14544050123966 | K051522 | 000 |
| 14544050123973 | K051522 | 000 |
| 14544050123980 | K051522 | 000 |
| 14544050123997 | K051522 | 000 |
| 14544050124000 | K051522 | 000 |
| 04544050061148 | K051522 | 000 |
| 04544050061186 | K051522 | 000 |
| 04544050061193 | K051522 | 000 |
| 04544050061209 | K051522 | 000 |
| 04544050083928 | K051522 | 000 |
| 04544050083935 | K051522 | 000 |
| 04544050083942 | K051522 | 000 |
| 04544050123938 | K051522 | 000 |