K983276 is an FDA 510(k) clearance for the HYDROFERA BACTERISTATIC NASAL DRESSING. This device is classified as a Balloon, Epistaxis (Class I - General Controls, product code EMX).
Submitted by Hydrofera, LLC (Willimantic, US). The FDA issued a Cleared decision on September 14, 1999, 362 days after receiving the submission on September 17, 1998.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4100.
| 510(k) Number | K983276 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 17, 1998 |
| Decision Date | September 14, 1999 |
| Days to Decision | 362 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Statement |
| Product Code | EMX - Balloon, Epistaxis |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 874.4100 |