K072404 is an FDA 510(k) clearance for the ERBE ERBEJET 2 SYSTEM. This device is classified as a Lavage, Jet (Class II - Special Controls, product code FQH).
Submitted by Erbe USA, Inc. (Marietta, US). The FDA issued a Cleared decision on October 31, 2007, 65 days after receiving the submission on August 27, 2007.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5475.
| 510(k) Number | K072404 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 27, 2007 |
| Decision Date | October 31, 2007 |
| Days to Decision | 65 days |
| Submission Type | Abbreviated |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FQH — Lavage, Jet |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5475 |