K993362 is an FDA 510(k) clearance for the HYLASINE. This device is classified as a Balloon, Epistaxis (Class I - General Controls, product code EMX).
Submitted by Biomatrix, Inc. (Ridgefield, US). The FDA issued a Cleared decision on March 13, 2000, 159 days after receiving the submission on October 6, 1999.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4100.
| 510(k) Number | K993362 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 06, 1999 |
| Decision Date | March 13, 2000 |
| Days to Decision | 159 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | EMX — Balloon, Epistaxis |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 874.4100 |