The following data is part of a premarket notification filed by Triumvirate Environmental, Inc. with the FDA for Red2green Reusable Sharps Container.
| Device ID | K153363 |
| 510k Number | K153363 |
| Device Name: | Red2Green Reusable Sharps Container |
| Classification | Container, Sharps |
| Applicant | TRIUMVIRATE ENVIRONMENTAL, INC. 200 INNER BELT ROAD Somerville, MA 02143 |
| Contact | Steve Todisco |
| Correspondent | Allison C. Komiyama AcKnowledge Regulatory Strategies 2834 Hawthorn St. San Diego, CA 92104 |
| Product Code | MMK |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-20 |
| Decision Date | 2016-07-26 |
| Summary: | summary |