K991670 is an FDA 510(k) clearance for the SILVERSTEIN MICROWICK. This device is classified as a Tube, Tympanostomy (Class II - Special Controls, product code ETD).
Submitted by Micromedics, Inc. (Eagan, US). The FDA issued a Cleared decision on August 26, 1999, 101 days after receiving the submission on May 17, 1999.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3880.
| 510(k) Number | K991670 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 17, 1999 |
| Decision Date | August 26, 1999 |
| Days to Decision | 101 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 |