K150518 is an FDA 510(k) clearance for the Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm. This device is classified as a Block, Bite (Class II - Special Controls, product code JXL).
Submitted by Dupaco, Inc. (Oceanside, US). The FDA issued a Cleared decision on June 29, 2015, 119 days after receiving the submission on March 2, 2015.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5070.
| 510(k) Number | K150518 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 02, 2015 |
| Decision Date | June 29, 2015 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | JXL — Block, Bite |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5070 |