K963856 is an FDA 510(k) clearance for the RAND NASAL PACKING. This device is classified as a Balloon, Epistaxis (Class I - General Controls, product code EMX).
Submitted by Rand Scientific Corp. (Sacramento, US). The FDA issued a Cleared decision on October 18, 1996, 23 days after receiving the submission on September 25, 1996.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4100.
| 510(k) Number | K963856 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 1996 |
| Decision Date | October 18, 1996 |
| Days to Decision | 23 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 |