K073276 is an FDA 510(k) clearance for the IONTOPHORESIS SYSTEM. This device is classified as a Device, Iontophoresis, Other Uses (Class II - Special Controls, product code EGJ).
Submitted by Acclarent, Inc. (Rmenlo Park, US). The FDA issued a Cleared decision on March 5, 2008, 105 days after receiving the submission on November 21, 2007.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5525.
| 510(k) Number | K073276 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 2007 |
| Decision Date | March 05, 2008 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | EGJ — Device, Iontophoresis, Other Uses |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5525 |