The following data is part of a premarket notification filed by King Systems Corp. with the FDA for King Lts Reusable Oropharyngeal Airway With Drain/suction Channel, Models Klt 303, Klt 304 And Klt 305.
| Device ID | K033189 |
| 510k Number | K033189 |
| Device Name: | KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305 |
| Classification | Airway, Oropharyngeal, Anesthesiology |
| Applicant | KING SYSTEMS CORP. 15011 HERRIMAN BLVD. Noblesville, IN 46060 |
| Contact | Tom Mcgrail |
| Correspondent | Tom Mcgrail KING SYSTEMS CORP. 15011 HERRIMAN BLVD. Noblesville, IN 46060 |
| Product Code | CAE |
| CFR Regulation Number | 868.5110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-01 |
| Decision Date | 2004-05-04 |
| Summary: | summary |