Submission Details
| 510(k) Number | K153537 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Sol-M Insulin Syringe, Sol-M TB Syringe
Jun 2016
Decision
190d
Days
Class 2
Risk
About This 510(k) Submission
K153537 is an FDA 510(k) clearance for the Sol-M Insulin Syringe, Sol-M TB Syringe, 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 review panel. Regulated under 21 CFR 880.5860.
Device Classification
| Product Code | FMF — Syringe, Piston |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5860 |
Manufacturer
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