K050998 is an FDA 510(k) clearance for the CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP, MODELS 20-5000, AP-A-6063. 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 June 15, 2005, 56 days after receiving the submission on April 20, 2005.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K050998 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 20, 2005 |
| Decision Date | June 15, 2005 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| 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 |