K910362 is an FDA 510(k) clearance for the TRACHEOSTOMY CARE KIT. This device is classified as a Tube Tracheostomy And Tube Cuff (Class II - Special Controls, product code JOH).
Submitted by Megadyne Medical Products, Inc. (Hauppauge, US). The FDA issued a Cleared decision on April 8, 1991, 69 days after receiving the submission on January 29, 1991.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5800.
| 510(k) Number | K910362 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 29, 1991 |
| Decision Date | April 08, 1991 |
| Days to Decision | 69 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | JOH — Tube Tracheostomy And Tube Cuff |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5800 |