K070814 is an FDA 510(k) clearance for the MODIFICATION TO CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Confluent Surgical,Inc (Waltham, US). The FDA issued a Cleared decision on May 30, 2007, 65 days after receiving the submission on March 26, 2007.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K070814 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 26, 2007 |
| Decision Date | May 30, 2007 |
| Days to Decision | 65 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMF — Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |