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 |