K981575 is an FDA 510(k) clearance for the TYMPANOSTOMY TUBE. This device is classified as a Tube, Tympanostomy (Class II - Special Controls, product code ETD).
Submitted by Grace Medical, Inc. (Bartlett, US). The FDA issued a Cleared decision on July 15, 1998, 72 days after receiving the submission on May 4, 1998.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3880.
| 510(k) Number | K981575 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 1998 |
| Decision Date | July 15, 1998 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Statement |
| Product Code | ETD - Tube, Tympanostomy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3880 |