The following data is part of a premarket notification filed by Well Lead Instruments with the FDA for Well Lead Endobronchial Tubes.
| Device ID | K092886 |
| 510k Number | K092886 |
| Device Name: | WELL LEAD ENDOBRONCHIAL TUBES |
| Classification | Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) |
| Applicant | WELL LEAD INSTRUMENTS 962 ALLEGRO LANE Apollo Beach, FL 33570 |
| Contact | Arthur Ward |
| Correspondent | Arthur Ward WELL LEAD INSTRUMENTS 962 ALLEGRO LANE Apollo Beach, FL 33570 |
| Product Code | CBI |
| CFR Regulation Number | 868.5740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-21 |
| Decision Date | 2010-03-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16944932759128 | K092886 | 000 |
| 16944932759401 | K092886 | 000 |
| 20815123012021 | K092886 | 000 |
| 10815123012031 | K092886 | 000 |
| 20815123012045 | K092886 | 000 |
| 20815123012052 | K092886 | 000 |
| 20815123012069 | K092886 | 000 |
| 20815123012076 | K092886 | 000 |
| 20815123012083 | K092886 | 000 |
| 16944932759395 | K092886 | 000 |
| 16944932759388 | K092886 | 000 |
| 16944932759135 | K092886 | 000 |
| 16944932759142 | K092886 | 000 |
| 16944932759159 | K092886 | 000 |
| 16944932759166 | K092886 | 000 |
| 16944932759173 | K092886 | 000 |
| 16944932759357 | K092886 | 000 |
| 16944932759364 | K092886 | 000 |
| 16944932759371 | K092886 | 000 |
| 20815123012090 | K092886 | 000 |
| 20815123012106 | K092886 | 000 |
| 20815123012113 | K092886 | 000 |
| 10607411959483 | K092886 | 000 |
| 20607411959497 | K092886 | 000 |
| 20607411959503 | K092886 | 000 |
| 20607411959510 | K092886 | 000 |
| 20607411959527 | K092886 | 000 |
| 20607411959534 | K092886 | 000 |
| 20607411959541 | K092886 | 000 |
| 10607411959551 | K092886 | 000 |
| 20607411959473 | K092886 | 000 |
| 20607411959466 | K092886 | 000 |
| 20815123012120 | K092886 | 000 |
| 20815123012137 | K092886 | 000 |
| 20607411959336 | K092886 | 000 |
| 20607411659342 | K092886 | 000 |
| 20607411659359 | K092886 | 000 |
| 20607411959367 | K092886 | 000 |
| 20607411959374 | K092886 | 000 |
| 10607411959384 | K092886 | 000 |
| 20607411959565 | K092886 | 000 |