K883668 is an FDA 510(k) clearance for the SUNDERLAND NASAL TUBE. This device is classified as a Airway, Nasopharyngeal (Class I — General Controls, product code BTQ).
Submitted by Exmoor Plastics , Ltd. (Taunton, GB). The FDA issued a Cleared decision on November 21, 1988, 87 days after receiving the submission on August 26, 1988.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5100.
| 510(k) Number | K883668 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 26, 1988 |
| Decision Date | November 21, 1988 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BTQ — Airway, Nasopharyngeal |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 868.5100 |