K803069 is an FDA 510(k) clearance for the SHELL KRATON THERMO-PLASTIC RUBBER COMP.. This device is classified as a Mouthpiece, Breathing (Class I - General Controls, product code BYP).
Submitted by Warren E. Collins, Inc. (Walker, US). The FDA issued a Cleared decision on December 22, 1980, 17 days after receiving the submission on December 5, 1980.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5620.
| 510(k) Number | K803069 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 1980 |
| Decision Date | December 22, 1980 |
| Days to Decision | 17 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BYP — Mouthpiece, Breathing |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5620 |