K822010 is an FDA 510(k) clearance for the RIGID SUCTION TIPS & RELATED ITEMS. This device is classified as a Tube, Ear Suction (Class I - General Controls, product code JZF).
Submitted by Kelleher Corp. (Mchenry, US). The FDA issued a Cleared decision on August 12, 1982, 35 days after receiving the submission on July 8, 1982.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4420.
| 510(k) Number | K822010 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 08, 1982 |
| Decision Date | August 12, 1982 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | — |
| Product Code | JZF — Tube, Ear Suction |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 874.4420 |