The following data is part of a premarket notification filed by Sol-millennium Medical, Inc with the FDA for 0.5ml Sol-care Retractable Safety Syringe With Fixed Needle.
| Device ID | K162030 |
| 510k Number | K162030 |
| Device Name: | 0.5ml Sol-Care Retractable Safety Syringe With Fixed Needle |
| Classification | Syringe, Antistick |
| Applicant | SOL-MILLENNIUM MEDICAL, INC 1735 NORTH BROWN ROAD, SUITE 120 Lawrenceville, GA 30043 |
| Contact | Jim Barley |
| Correspondent | Jim Barley SOL-MILLENNIUM MEDICAL, INC 1735 NORTH BROWN ROAD, SUITE 120 Lawrenceville, GA 30043 |
| Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-22 |
| Decision Date | 2016-08-19 |
| Summary: | summary |