K071027 is an FDA 510(k) clearance for the TRIBOGLIDE LUBRICATED SILICONE-FREE SYRINGE. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Tribofilm Research, Inc. (Raleigh, US). The FDA issued a Cleared decision on July 20, 2007, 100 days after receiving the submission on April 11, 2007.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K071027 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 11, 2007 |
| Decision Date | July 20, 2007 |
| Days to Decision | 100 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 |