The following data is part of a premarket notification filed by The Laryngeal Mask Co.,ltd. with the FDA for Lma Family Of Airways.
| Device ID | K130304 |
| 510k Number | K130304 |
| Device Name: | LMA FAMILY OF AIRWAYS |
| Classification | Airway, Oropharyngeal, Anesthesiology |
| Applicant | THE LARYNGEAL MASK CO.,LTD. 2917 WECK DR PO BOX 12600 Research Triangle Park, NC 27709 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden THE LARYNGEAL MASK CO.,LTD. 2917 WECK DR PO BOX 12600 Research Triangle Park, NC 27709 |
| Product Code | CAE |
| CFR Regulation Number | 868.5110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-07 |
| Decision Date | 2014-05-30 |