The following data is part of a premarket notification filed by The Laryngeal Mask Co.,ltd. with the FDA for Lma Fastrach Ett Single Use.
| Device ID | K051993 |
| 510k Number | K051993 |
| Device Name: | LMA FASTRACH ETT SINGLE USE |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | THE LARYNGEAL MASK CO.,LTD. 9360 TOWNE CENTRE DR. San Diego, CA 92121 |
| Contact | Foster Boop |
| Correspondent | Foster Boop THE LARYNGEAL MASK CO.,LTD. 9360 TOWNE CENTRE DR. San Diego, CA 92121 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-25 |
| Decision Date | 2005-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15060112311823 | K051993 | 000 |
| 15060112311816 | K051993 | 000 |
| 15060112311809 | K051993 | 000 |
| 15060112311793 | K051993 | 000 |
| 15060112310598 | K051993 | 000 |
| 25060112310588 | K051993 | 000 |
| 25060112310571 | K051993 | 000 |
| 25060112310564 | K051993 | 000 |
| 25060112310557 | K051993 | 000 |