The following data is part of a premarket notification filed by The Laryngeal Mask Co.,ltd. with the FDA for Lma Stonebreaker Device; Probe Size 1.0mm, 1.6mm, 2.0mm.
| Device ID | K062475 |
| 510k Number | K062475 |
| Device Name: | LMA STONEBREAKER DEVICE; PROBE SIZE 1.0MM, 1.6MM, 2.0MM |
| Classification | Lithotriptor, Electro-hydraulic |
| Applicant | THE LARYNGEAL MASK CO.,LTD. 4660 LA JOLLA VILLAGE DRIVE San Diego, CA 92122 |
| Contact | Foster Boop |
| Correspondent | Foster Boop THE LARYNGEAL MASK CO.,LTD. 4660 LA JOLLA VILLAGE DRIVE San Diego, CA 92122 |
| Product Code | FFK |
| CFR Regulation Number | 876.4480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-24 |
| Decision Date | 2007-05-09 |
| Summary: | summary |