K933412 is an FDA 510(k) clearance for the SALINE SOLUTION-STERILE. This device is classified as a Tube Tracheostomy And Tube Cuff (Class II — Special Controls, product code JOH).
Submitted by Trinity Laboratories, Inc. (Salisbury, US). The FDA issued a Cleared decision on October 1, 1993, 80 days after receiving the submission on July 13, 1993.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5800.
| 510(k) Number | K933412 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 1993 |
| Decision Date | October 01, 1993 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | JOH — Tube Tracheostomy And Tube Cuff |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5800 |