K973587 is an FDA 510(k) clearance for the EXMOOR TYMPANOCENTESIS KIT (TK/1). This device is classified as a Tube, Ear Suction (Class I — General Controls, product code JZF).
Submitted by Exmoor Plastics , Ltd. (Taunton, GB). The FDA issued a Cleared decision on January 23, 1998, 123 days after receiving the submission on September 22, 1997.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4420.
| 510(k) Number | K973587 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent — Traditional 510(k) (SESE) |
| Date Received | September 22, 1997 |
| Decision Date | January 23, 1998 |
| Days to Decision | 123 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | JZF — Tube, Ear Suction |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 874.4420 |