The following data is part of a premarket notification filed by The Laryngeal Mask Co.,ltd. with the FDA for Ilm Endotracheal Tube.
| Device ID | K991580 |
| 510k Number | K991580 |
| Device Name: | ILM ENDOTRACHEAL TUBE |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | THE LARYNGEAL MASK CO.,LTD. 12300 TWINBROOK PKWY. Rockville, MD 20852 |
| Contact | Robert L Sheridan |
| Correspondent | Robert L Sheridan THE LARYNGEAL MASK CO.,LTD. 12300 TWINBROOK PKWY. Rockville, MD 20852 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-07 |
| Decision Date | 2000-02-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35060112310486 | K991580 | 000 |
| 35060112310479 | K991580 | 000 |
| 35060112310462 | K991580 | 000 |
| 35060112310455 | K991580 | 000 |
| 35060112310448 | K991580 | 000 |