K921353 is an FDA 510(k) clearance for the NASOPHARYNGEAL AIRWAY. This device is classified as a Airway, Nasopharyngeal (Class I - General Controls, product code BTQ).
Submitted by Coast Medical Corp. (Orange, US). The FDA issued a Cleared decision on June 11, 1992, 84 days after receiving the submission on March 19, 1992.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5100.
| 510(k) Number | K921353 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 19, 1992 |
| Decision Date | June 11, 1992 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BTQ — Airway, Nasopharyngeal |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5100 |