K153537 is an FDA 510(k) clearance for the Sol-M Insulin Syringe, Sol-M TB Syringe. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Sol-Millennium Medical, Inc. (Lawrenceville, US). The FDA issued a Cleared decision on June 17, 2016, 190 days after receiving the submission on December 10, 2015.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K153537 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 10, 2015 |
| Decision Date | June 17, 2016 |
| Days to Decision | 190 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 |