The following data is part of a premarket notification filed by Well Lead Medical Co. Ltd with the FDA for Well Lead Endotracheal Tube With Evacuation Lumen-oral.
| Device ID | K110269 |
| 510k Number | K110269 |
| Device Name: | WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORAL |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | WELL LEAD MEDICAL CO. LTD 962 ALLEGRO LANE Apollo Beach, FL 33572 |
| Contact | John Obrien |
| Correspondent | John Obrien WELL LEAD MEDICAL CO. LTD 962 ALLEGRO LANE Apollo Beach, FL 33572 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-27 |
| Decision Date | 2011-08-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20851785007654 | K110269 | 000 |
| 20888277657318 | K110269 | 000 |
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| 10888277717671 | K110269 | 000 |
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| 20851785007593 | K110269 | 000 |
| 00851785007582 | K110269 | 000 |
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| 34026704647744 | K110269 | 000 |
| 16944932729633 | K110269 | 000 |