K963550 is an FDA 510(k) clearance for the RINOFLOW MICRONIZED E.N..T. WASH SYTSTEM. This device is classified as a Irrigator, Powered Nasal (Class I - General Controls, product code KMA).
Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on November 1, 1996, 57 days after receiving the submission on September 5, 1996.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.5550.
| 510(k) Number | K963550 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 05, 1996 |
| Decision Date | November 01, 1996 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | KMA — Irrigator, Powered Nasal |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 874.5550 |