K933781 is an FDA 510(k) clearance for the ANTI-DISCONNECTION MECHANISM. This device is classified as a Device, Fixation, Tracheal Tube (Class I - General Controls, product code CBH).
Submitted by Hammer-Plane, Inc. (Simi Valley, US). The FDA issued a Cleared decision on September 22, 1993, 49 days after receiving the submission on August 4, 1993.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5770.
| 510(k) Number | K933781 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 1993 |
| Decision Date | September 22, 1993 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | CBH — Device, Fixation, Tracheal Tube |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5770 |