K942746 is an FDA 510(k) clearance for the SUCKER ENDS (ZOELLNER). This device is classified as a Instrument, Ent Manual Surgical (Class I — General Controls, product code LRC).
Submitted by Exmoor Plastics , Ltd. (Taunton, GB). The FDA issued a Cleared decision on August 24, 1994, 75 days after receiving the submission on June 10, 1994.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4420.
| 510(k) Number | K942746 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 10, 1994 |
| Decision Date | August 24, 1994 |
| Days to Decision | 75 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Statement |
| Product Code | LRC — Instrument, Ent Manual Surgical |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 874.4420 |