K093594 is an FDA 510(k) clearance for the MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER. This device is classified as a Cannula, Sinus (Class I - General Controls, product code KAM).
Submitted by Acclarent, Inc. (Rmenlo Park, US). The FDA issued a Cleared decision on March 3, 2010, 104 days after receiving the submission on November 19, 2009.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K093594 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 19, 2009 |
| Decision Date | March 03, 2010 |
| Days to Decision | 104 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KAM — Cannula, Sinus |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |