K972459 is an FDA 510(k) clearance for the RHINOCELL NASAL PACKINGS. This device is classified as a Balloon, Epistaxis (Class I - General Controls, product code EMX).
Submitted by Boston Medical Products, Inc. (Westborough, US). The FDA issued a Cleared decision on August 4, 1997, 34 days after receiving the submission on July 1, 1997.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4100.
| 510(k) Number | K972459 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 1997 |
| Decision Date | August 04, 1997 |
| Days to Decision | 34 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 |